HEARTWARE® VENTRICULAR ASSIST SYSTEM
Report
- Report Number
- 3007042319-2015-01295
- Event Type
- Malfunction
- Date Received
- June 26, 2015
- Date of Event
- August 11, 2014
- Report Date
- June 23, 2015
- Manufacturer
- HEARTWARE, INC
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-1607-2014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. A CONTROLLER AND SIX BATTERIES WERE RETURNED FOR INVESTIGATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED SCREEN BATTERIES IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE DEVICES REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. ANALYSIS OF THE DEVICES REVEALED THAT THE CONTROLLERS AND SCREENED BATTERIES MET SPECIFICATIONS. AN EVALUATION OF RETURNED BATTERIES (B)(4) WAS NOT PERFORMED AS THESE BATTERIES PERTAIN TO THE RECALL FSCA APR2014.1; THEREFORE, PRODUCT EVALUATION IS NOT REQUIRED. THE RETURNED BATTERIES (B)(4) PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING IN A LAB ENVIRONMENT. THE RETURNED CONTROLLER (B)(4) PASSED VISUAL AND FUNCTIONAL TESTING. SYSTEM TESTING DID NOT INDICATE ANY ABNORMAL OPERATION OF THE CONTROLLER. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED MULTIPLE POWER SWITCHING EVENTS. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH POWER SWITCHING OF SCREENED BATTERIES ARE MOST OFTEN ATTRIBUTED TO COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERY. POWER SWITCHING EVENTS INVOLVING UNSCREENED BATTERIES ARE MOST OFTEN ATTRIBUTED TO A FAULTY CELL. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. THERE ARE NO KNOWN CLINICAL OR USER RELATED FACTORS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE MOST LIKELY ROOT CAUSE OF THE REPORTED 'POWER SWITCHING' EVENT IS A COMBINATION OF BATTERIES WITH FAULTY CELLS AND A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERIES. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. PER THE INSTRUCTIONS FOR USE (IFU): PATIENTS ARE INSTRUCTED TO ALWAYS KEEP A SPARE SET OF FULLY CHARGED BATTERIES AVAILABLE AT ALL TIMES, BEYOND THE TWO (2) POWER SOURCES THAT ARE CURRENTLY CONNECTED TO THE CONTROLLER. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS THREE OF SEVEN REPORTS (3007042319-2014-01133 AND 3007042319-2015-1282, 1311, 1294, 1295, 1310, 1312) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803.
APPROXIMATELY TWO YEARS, TWO MONTHS AND TWO WEEKS POST HVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PREMATURE SWITCHING FROM ONE PORT OF THE CONTROLLER TO THE OTHER. ALL THE BATTERIES AND THE CONTROLLER WERE REPLACED. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416148 | HEARTWARE® VENTRICULAR ASSIST SYSTEM | CIRCULATORY ASSIST SYSTEM | DSQ | HEARTWARE, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4) - BATTERY| (B)(4) - BATTERY| (B)(4) - CONTROLLER| (B)(4) - BATTERY| (B)(4) - BATTERY| (B)(4) - BATTERY |