NCPS Patient Safety Alert and Patient Safety Advisory Development Process
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
| December 19, 2011 | Alert |
Software upgrade to resolve Bayer Viterion V100 BGM
Home Telehealth hub device not transmitting all of Roche
Accu-Chek Aviva blood glucose meters' data via Roche
infrared peripheral. Replaces and supersedes Patient Safety Alert AL11-03 issued April 27, 2011 AL12-01 |
| September 12, 2011 | Alert |
Look-Alike Hemodialysis Solutions AL11-09 |
| June 28, 2011 | Alert |
Potential anchor points for hanging in mental health units treating actively suicidal patients and other areas treating or holding suicidal patients that are not on 1:1 observation (e.g., psychiatric holding areas in emergency departments) AL11-08 |
| June 28, 2011 | Alert |
Furniture floor guards in mental health units treating actively suicidal patients and other areas treating or holding suicidal patients that are not on 1:1 observation (e.g., psychiatric holding areas in emergency departments) AL11-07 |
| June 28, 2011 | Alert |
Walker used to barricade a sleeping room door on a locked inpatient mental health unit treating currently suicidal patients AL11-06 |
| April 8, 2011 | Alert
|
Use of elastic-hemmed fitted bed sheets in mental health units and other units holding or treating actively suicidal patients FAQS for AL11-02 Revised 4/19/2011 |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
| October 25, 2010 | Alert
|
Standardized Process for Insulin Orders when used in Patient Controlled Insulin Pumps *The software referenced in AL11-01* includes VA Computerized Patient Record System (CPRS) v1.0.27.90, Bar Code Medication Administration (BCMA) v3.0.32.47, and uses Veterans Health Information Systems and Technology Architecture (VistA) Inpatient Medication Package v5.0. |
| August 2, 2010 | Advisory
|
Epinephrine, Phenylephrine, and other High Alert Medication Safety in the Operating Room AD10-03 |
| July 7, 2010 | Alert
|
Hepatitis C virus (HCV) testing using Novartis Chiron RIBA HCV 3.0 Strip Immunoblot Assay (SIA) reagents |
| July 7, 2010 | Alert
|
Redsense® Dialysis Alarm for Patients Undergoing Needle Access Procedures FAQS for AL10-13 Revised 10/29/2010 |
May 13, 2010 | Alert
|
Philips IntelliVue Non Invasive Blood Pressure (NIBP) monitors may display only Mean Arterial Pressure (MAP) results: Models MP20/30/40/50/60/70/80/90 AL10-11 |
| May 4, 2010 | Alert
|
Hospital-grade power cords, manufactured by Electri-Cord and sold to medical equipment manufacturers AL10-10 |
| March 22, 2010 | Alert
|
Ceiling mounted patient lift installations AL10-07 |
| February 17, 2010 | Advisory
|
Misidentification of patient resulting in delay of surgery AD10-01 |
| February 3, 2010 | Alert
|
Fresenius HemaClip used during dialysis AL10-05 |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
| December 14, 2009 | Alert
|
Possible blood contamination in hemodialysis machines AL10-04 |
| October 6, 2009 | Alert
|
Attempted hanging from a door in a locked mental health unit AL10-03 |
| October 1, 2009 | Alert
|
Glucose Monitoring Test Strips that utilize Glucose Dehydrogenase Pyrroloquinoline Quinone (GDH-PQQ) methodology may give falsely elevated glucose results AL10-01 |
| September 2, 2009 | Alert
|
Operable exterior windows in locked inpatient mental health units AL09-25 |
| August 6, 2009 | Alert
|
Medtronic SynchroMed II Implantable Drug Infusion Pump; Models: 8637-20 and 8637-40 AL09-24 |
| July 10, 2009 | Advisory
|
Alarms on bedside physiological monitors AD09-09 |
| June 16, 2009 | Alert
|
Philips IntelliVue G1/G5 Anesthesia Gas Modules:
Model Numbers M1013A and M1019A and
Dräger Apollo Anesthesia Machines and Multigas Monitor:
Model SCIO AL09-23 |
| June 8, 2009 | Alert
|
Physician Advisory issued by Medtronic Inc. on subsets of:
Kappa 600/700/900 series dual chamber and single chamber
pacemakers and Sigma 100/200/300 series dual chamber and
single chamber cardiac pacemakers AL09-22 |
| May 4, 2009 | Alert
|
Arjo Carendo Shower Chair Model BIB 2003-01 or BIB2003-01KT AL09-21 |
| April 22, 2009 | Alert |
Transvaginal Placement of Surgical Mesh AL09-20 |
| April 3, 2009 | Alert |
CPRS – Changing Medication Schedule may Leave Incorrect
Medication Administration Times AL09-19 |
| March 24, 2009 | Alert |
AEDPlus Public Access Automated External Defibrillators (AEDs), manufactured by Zoll. AL09-17 |
| March 5, 2009 | Alert |
Cylinder Valve Explodes from Oxygen Cylinder supplied with
Rotarex/Ceodeux Post Type Cylinder Valve AL09-16 |
| March 3, 2009 | Alert |
Medication Safety- Insulin U-500 Safety Enhancements AL09-15 |
| February 20, 2009 | Alert |
Medtronic InFuse Recombinant Human Bone Morphogenetic
Protein in Cervical Spine Fusion AL09-13 |
| February 19, 2009 | Advisory
|
Cardinal Health’s Alaris System Infusion Pumps AD09-07 |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
| December 30 , 2008 | Advisory |
Suicide attempt in the Emergency Room (ER) AD09-05 |
| December 22 , 2008 | Alert |
Improper set-up and reprocessing of flexible endoscope tubing and accessories AL09-07 |
| November 20, 2008 | Alert |
Maxi Move patient lifts with "Lock and Load" system (Combi Hanger): Manufactured by Arjo between November 2005 and April 2008 AL09-06 |
| October 27, 2008 | Alert |
Baxter Single Strength Dosing Card for BREVIBLOC Premixed Injection (esmolol HCl) 2,500 mg/250 mL (10 mg/mL) Ready-to-use-Bags, 250 mL bags AL09-03 |
| October 24, 2008 | Alert |
Medtronic Neuromodulation Sutureless Connector Catheters used with SynchroMed and IsoMed implantable infusion pumps:
|
| October 21, 2008 | Advisory |
Methicillin-resistant Staphylococcus aureus (MRSA) contamination in an orthopedic clinic room AD09-03 |
| October 21, 2008 | Advisory |
Bleeding episodes during dialysis AD09-02 |
| October 10, 2008 | Alert |
Shower curtains in locked mental health units AL09-01 |
| March 31, 2008 | Alert |
Improper reprocessing of flexible endoscope biopsy valves |
| March 12, 2008 | Alert |
STERIS C1160 Universal Flexible Processing Trays used with the STERIS
System 1 Sterile Processing Systems AL08-11 |
| January 25, 2008 | Alert |
Implant orientation of Implantable Cardioverter Defibrillators (ICDs) and Cardiac
Resynchronization Therapy Devices (CRT-Ds) manufactured by Boston Scientific
Corporation’s Cardiac Rhythm Management Division, previously under the name
Guidant. AL08-07 |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
| December 21, 2007 | Alert |
FDA CLASS II recall of Boston Scientific Corporation's Cardiac Rhythm Management Division (previously called Guidant) Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). AL08-06 |
| December 7, 2007 | Advisory |
Positive displacement, needle-free intravascular connector valves AD08-01 |
| November 29, 2007 | Alert |
Model 8100 infusion pump modules shipped before September 27, 2007; a
component of the Alaris Medley infusion pump system, distributed by Cardinal
Health. AL08-04 |
| October 25, 2007 | Alert |
Sprint Fidelis® Defibrillation Leads, manufactured by Medtronic AL08-02 |
| October 23, 2007 | Alert |
Medtronic SynchroMed EL implantable infusion pump;
models: 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18,
8627L-18. AL08-01 |
| April 18, 2007 | Alert |
Boston Scientific Corporation's Cardiac Rhythm Management Division (previously
called Guidant) recall of Implantable Cardiac Defibrillators (ICDs) and Cardiac
Resynchronization Therapy Defibrillators (CRT-Ds). AL07-07 |
| February 16 , 2007 | Alert |
Privacy curtains in locked mental health wards AL07-04 |
| February 14, 2007 | Advisory |
Daylight Savings Time (DST) changes AD07-04 |
| January 31, 2007 | Advisory |
Reprocessing of resectoscope system’s working elements AD07-03 |
| January 8, 2007 | Advisory |
Gemini PC series infusion pumps manufactured by Alaris,
formerly IMED AD07-01 |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
| August 30, 2006 | Alert |
All models of Alaris® SE infusion pumps - formerly the Signature
Edition® Infusion System. Alaris is a subsidiary of Cardinal Health, Inc. AL06-16 |
| July 24, 2006 | Alert |
Sealed, lead-acid batteries for external defibrillators supplied by non-OEM (Original Equipment Manufacturer) or second source suppliers. Second source suppliers
include Alpha Source, Anybattery, R&D Batteries and Unipower, among others. AL06-15 |
| June 28, 2006 | Alert |
Boston Scientific/Guidant Recall AL06-14 |
| April 6, 2006 | Alert |
Mix-up (wrong route of administration) of bladder irrigation with intravenous (IV) infusions AL06-12 |
| April 3, 2006 | Alert |
Transrectal ultrasound transducer assembly, Models 8808 and 8551, manufactured by B-K Medical Systems, Inc., Wilmington, MA AL06-11 |
February 8, 2006 |
Alert |
Cessation of Topical Spray Benzocaine Usage to Anesthetize the Surfaces of the Nasopharynx, Oropharynx, Laryngotracheal Region and Airway AL06-09 |
| January 10, 2006 | Advisory |
Ipump Pain Management System, APII Infusion Pump and PCAII Infusion Pump, manufactured by Baxter Healthcare Corporation. AD06-03 |
| January 9, 2006 | Alert |
Physician Advisory issued by Medtronic Inc. on the Sigma Series single and dual chamber pacemakers (SD203, SD303, SDR203, SDR303, SDR306, SVDD303, SS103, SS106, SS203, SS303, SSR203, SSR303, SSR306, SVVI103) AL06-08 |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
December 21, 2005 |
Alert |
Injector connector relays on patient tables manufactured by Philips Medical, table models AD5 and AD6 used with the Integris, Integris Allura and Allura Xper x-ray systems.) AL06-06 |
November 1, 2005 |
Alert | Heat maintainers for Stellant CT Injector Systems, manufactured by MEDRAD, Inc. Part numbers for the heat maintainers are 3007871, 3007872, 3009707 and 3009708. (Note: Part numbers for the Stellant injector systems are 3007301, 3010432, 3007300 and 3010091.) AL06-04 |
June 8, 2005 |
Alert | Guidant Model 1861 Ventak Prizm 2 DR, Implantable Cardioverter-Defibrillators (ICD) manufactured before November 2002 AL05-13 |
May 31, 2005 |
Alert | Blood Glucose Monitors (Glucometers), models OneTouch, Ultra, InDuo, and OneTouch FastTake manufactured by LifeScan, Inc. AL05-11 |
March 29, 2005 |
Alert | Enclosed Bed systems manufactured by Vail Products Inc, models: 500, 1000, and 2000. AL05-09 |
February 28, 2005 |
Alert | Louvered heating, ventilating and air conditioning (HVAC) grilles in locked Behavioral Health Units. AL05-06 |
January 12, 2005 |
Alert | Nellcor pulse oximeters, model 595 and limited quantities of models 395, 295 and 290 Nellcor 595 Alert |
January 10, 2005 |
Advisory | Depression Screening for Veteran Patients Recently Separated from Active Military Duty Depression Screening Advisory |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
November 9, 2004 |
Advisory | Electro-magnetic Interference (EMI) from the use of two-way hand held radios/ walkie-talkies in close proximity to medical devices. EMI Advisory |
October 21, 2004 |
Advisory | ALARIS (IMED) Gemini Infusion Pumps Alaris Gemini Advisory |
July 2, 2004 |
Alert | Failure of medical alarm systems using paging technology to notify clinical staff Alarm Paging Alert |
June 2, 2004 |
Alert | Minor Surgery/Exam lights: CoolSpot™ and Outpatient® Fleximount™ Single Ceiling and Track Mount with Single Trolley manufactured by Burton Medical before August 2000. Burton Lights Alert |
April 28, 2004 |
Alert | Implantable Cardioverter Defibrillators (ICD) manufactured by Medtronic Medtronic ICD Alert |
April 28, 2004 |
Advisory | Drug File View from CPRS CPRS Drug File Advisory |
April 5, 2004 |
Alert | Oxygen Utility System Oxygen Utility System Alert |
February 13, 2004 |
Alert | Connectors for Sterilization of all Gastrointestinal Fiberoptic Endoscopes |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
November 4, 2003 |
Alert | J&J Cordis CypherTM Sirolimus-Eluting Coronary Stent |
July 21, 2003 |
Alert | Soft Skin protective sleeve |
July 14, 2003 |
Alert | Power cords for Hill-Rom Century+ electric beds |
June 18, 2003 |
Alert | Decimal point display - Abbott APM II pump |
June 18, 2003 |
Alert | In-line air filter requirement for Abbott Pumps |
March 6, 2003 |
Advisory | Olympus EXERA Gastrointestinal Endoscopes |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
September 30, 2002 |
Advisory | Cochlear Implant Risk |
July 22, 2002 |
Advisory | SSCOR Suction Pumps |
May 28, 2002 |
Advisory | ADDENDUM to Advisory for Allegiance Irrigation Kits |
February 27, 2002 |
Advisory | Potential for incorrectly attaching Allegiance Irrigation Kit caps to Foley catheters |
January 23, 2002 |
Alert | Zoll M Series defibrillators and M Series Automated External Defibrillators |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
August 15, 2001 |
Advisory | Risperidone oral medication syringe (pipette) |
July 13, 2001 |
Alert | Bed Rail Entrapment For additional information see the 1995 FDA Alert |
February 5, 2001 |
Alert | Magnetic Resonance Imaging (MRI) systems |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
January 3, 2000 |
Alert | Ventilators - All Makes/Models |