VHA National Center for Patient Safety

Use of Thermal Fuses May Reduce the Severity of Fires Involving Home Oxygen Delivery Systems.

Table Tipping Risk with GE Healthcare Infinia Nuclear Medicine Imaging Systems.

GE dual-head gamma cameras: Unintended movement can cause serious injury or death.

Please note: This Patient Safety Alert affects a more comprehensive list of dual-headed gamma cameras than in previous communications. AL 13-08 amended by AL13-08 Addendum and AL 13-08 Addendum #2.

Incorrect eye surgery adverse events in Veterans Health Administration facilities

Increased risk of metabolic alkalosis with acetate-containing dialysis acid concentrates that can cause cardiac arrest, arrhythmias and low blood pressure in dialysis patients

AL13-02

High vacuum/high flow suction devices, used inappropriately, have resulted in patient injuries and death

Certain lots of Ethicon HARMONIC® HPBLUE and HP054 hand pieces are not compatible with the Ethicon HARMONIC® Generator Model 300 (GEN04)

Incorrect Patient Information Displayed in VA's Computerized Patient Record System (CPRS) v28

Plastic cards can be used to disable locks in inpatient mental health and Emergency Department (ED) settings treating patients who have the potential for unpredictable or unsafe behavior (e.g., violence, suicide, etc.) and are not on 1:1 observation

Disassembly of wheelchairs in inpatient mental health and emergency department (ED) settings treating patients who have the potential for unpredictable or unsafe behavior (e.g., violence, suicide, etc.) and are not on 1:1 observation

Issues identified with Identity Management in commercial Clinical Information Systems/Anesthesia Record Keeping (CIS/ARK) systems in use at VA facilities.

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

Look-Alike Hemodialysis Solutions

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)

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)

Walker used to barricade a sleeping room door on a locked inpatient mental health unit treating currently suicidal patients

Use of elastic-hemmed fitted bed sheets in mental health units and other units holding or treating actively suicidal patients

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.

Hepatitis C virus (HCV) testing using Novartis Chiron RIBA HCV 3.0 Strip Immunoblot Assay (SIA) reagents

Redsense® Dialysis Alarm for Patients Undergoing Needle Access Procedures

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

Hospital-grade power cords, manufactured by Electri-Cord and sold to medical equipment manufacturers

Ceiling mounted patient lift installations

Misidentification of patient resulting in delay of surgery

Fresenius HemaClip used during dialysis

Possible blood contamination in hemodialysis machines

Attempted hanging from a door in a locked mental health unit

Glucose Monitoring Test Strips that utilize Glucose Dehydrogenase Pyrroloquinoline Quinone (GDH-PQQ) methodology may give falsely elevated glucose results

Operable exterior windows in locked inpatient mental health units

Medtronic SynchroMed II Implantable Drug Infusion Pump; Models: 8637-20 and 8637-40

Alarms on bedside physiological monitors

Philips IntelliVue G1/G5 Anesthesia Gas Modules: Model Numbers M1013A and M1019A and Dräger Apollo Anesthesia Machines and Multigas Monitor: Model SCIO

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

Arjo Carendo Shower Chair Model BIB 2003-01 or BIB2003-01KT

Transvaginal Placement of Surgical Mesh

AEDPlus Public Access Automated External Defibrillators (AEDs), manufactured by Zoll.

Cylinder Valve Explodes from Oxygen Cylinder supplied with Rotarex/Ceodeux Post Type Cylinder Valve

Medtronic InFuse Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion

AL09-13

Cardinal Health’s Alaris System Infusion Pumps

Suicide attempt in the Emergency Room (ER)

Improper set-up and reprocessing of flexible endoscope tubing and accessories

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

Medtronic Neuromodulation Sutureless Connector Catheters used with SynchroMed and IsoMed implantable infusion pumps:

INDURA One-Piece (1P) Intrathecal Catheters, Model 8709SC
Intrathecal Catheters, Model 8731SC
Sutureless Pump Connector Revision Kit, Model 8578
Intrathecal Catheter Pump Segment Revision Kit, Model 8596SC

Methicillin-resistant Staphylococcus aureus (MRSA) contamination in an orthopedic clinic room

Bleeding episodes during dialysis

Shower curtains in locked mental health units

Improper reprocessing of flexible endoscope biopsy valves

STERIS C1160 Universal Flexible Processing Trays used with the STERIS System 1 Sterile Processing Systems

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.

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).

Positive displacement, needle-free intravascular connector valves

Model 8100 infusion pump modules shipped before September 27, 2007; a component of the Alaris Medley infusion pump system, distributed by Cardinal Health.

Sprint Fidelis® Defibrillation Leads, manufactured by Medtronic

Medtronic SynchroMed EL implantable infusion pump; models: 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18.

Boston Scientific Corporation's Cardiac Rhythm Management Division (previously called Guidant) recall of Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds).

Privacy curtains in locked mental health wards

Daylight Savings Time (DST) changes

AD07-04

Reprocessing of resectoscope system’s working elements

All models of Alaris® SE infusion pumps — formerly the Signature Edition® Infusion System. Alaris is a subsidiary of Cardinal Health, Inc.

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.

Boston Scientific/Guidant Recall

Mix-up (wrong route of administration) of bladder irrigation with intravenous (IV) infusions

Transrectal ultrasound transducer assembly, Models 8808 and 8551, manufactured by B-K Medical Systems, Inc., Wilmington, MA

Cessation of Topical Spray Benzocaine Usage to Anesthetize the Surfaces of the Nasopharynx, Oropharynx, Laryngotracheal Region and Airway

Attachment A Updated 8/11/06

Ipump Pain Management System, APII Infusion Pump and PCAII Infusion Pump, manufactured by Baxter Healthcare Corporation.

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)

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.)

Guidant Model 1861 Ventak Prizm 2 DR, Implantable Cardioverter-Defibrillators (ICD) manufactured before November 2002

Blood Glucose Monitors (Glucometers), models OneTouch, Ultra, InDuo, and OneTouch FastTake manufactured by LifeScan, Inc.

Enclosed Bed systems manufactured by Vail Products Inc, models: 500, 1000, and 2000.

Louvered heating, ventilating and air conditioning (HVAC) grilles in locked Behavioral Health Units.

Nellcor pulse oximeters, model 595 and limited quantities of models 395, 295 and 290

Depression Screening for Veteran Patients Recently Separated from Active Military Duty

Electro-magnetic Interference (EMI) from the use of two-way hand held radios/ walkie-talkies in close proximity to medical devices.

Failure of medical alarm systems using paging technology to notify clinical staff

Implantable Cardioverter Defibrillators (ICD) manufactured by Medtronic

Drug File View from CPRS

Oxygen Utility System

Connectors for Sterilization of all Gastrointestinal Fiberoptic Endoscopes

J&J Cordis CypherTM Sirolimus-Eluting Coronary Stent

Soft Skin protective sleeve

Decimal point display - Abbott APM II pump

In-line air filter requirement for Abbott Pumps

Olympus EXERA™ Gastrointestinal Endoscopes

Cochlear Implant Risk

SSCOR Suction Pumps

ADDENDUM to Advisory for Allegiance Irrigation Kits

Potential for incorrectly attaching Allegiance Irrigation Kit caps to Foley catheters

Zoll M Series defibrillators and M Series Automated External Defibrillators

Risperidone oral medication syringe (pipette)

Bed Rail Entrapment

Magnetic Resonance Imaging (MRI) systems