HEARTWARE® VENTRICULAR ASSIST SYSTEM
Report
- Report Number
- 3007042319-2015-04180
- Event Type
- Malfunction
- Date Received
- December 29, 2015
- Date of Event
- December 8, 2015
- Report Date
- December 8, 2015
- Manufacturer
- HEARTWARE, INC
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
FOUR BATTERIES AND ONE CAC ADAPTER WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE DEVICES MET SPECIFICATIONS; THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED SEVERAL OCCURRENCES OF PREMATURE POWER SWITCHING PRIOR TO THE 25% THRESHOLD INVOLVING BATTERIES (B)(4). THESE PREMATURE SWITCHING EVENTS WERE MOST LIKELY CAUSED BY A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERIES. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. IN ADDITION, ANALYSIS OF THE RETURNED CAC ADAPTER REVEALED THAT THE DEVICE FAILED TO MEET SPECIFICATIONS; THE DEVICE FAILED VISUAL INSPECTION AND FUNCTIONAL TESTING AS A RESULT OF AN OPEN WIRE THAT WAS CREATING AN UNSTABLE DC VOLTAGE OUTPUT. THIS OBSERVATION IS CONSIDERED NOT RELATED TO THE REPORTED EVENT AND WAS MOST LIKELY CAUSED BY MISHANDLING. ADDITIONAL SYSTEM COMPONENT BEING REPORTED FOR THIS EVENT: CAC: (B)(4) - (B)(4); BATTERY: (B)(4) - EXPIRATION DATE: 03-31-20216, (B)(4); BATTERY: (B)(4) - EXPIRATION DATE: 03-31-20216, (B)(4); BATTERY: (B)(4) - EXPIRATION DATE: 03-31-20216, (B)(4). THIS IS FOUR OF FOUR REPORTS (3007042319-2015-04177, 3007042319-2015-04178, 3007042319-2015-04179 AND 3007042319-2015-04180) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF BATTERIES AND CONTROLLERS ARE OUTLINED. 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
THIS IS ONE OF FOUR REPORTS (3007042319-2015-04177, 3007042319-2015-04178, 3007042319-2015-04179 AND 3007042319-2015-04180) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.
IT WAS REPORTED BY THE SITE THAT THE PATIENT OBSERVED SINGLE BEEPS AND SWITCHING IN POWER SOURCES, REPORTED IN SEVERAL LEVELS OF CHARGING LEVEL. PATIENT HAS STATED TO HAVE EXPERIENCED THESE ISSUES IN SEVERAL SITUATIONS BEFORE. IT WAS ALSO STATED THAT THERE WERE NO EFFECT OR CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED. INVESTIGATION IS ONGOING.
IT WAS REPORTED BY THE SITE THAT THE PATIENT OBSERVED SINGLE BEEPS AND SWITCHING IN POWER SOURCES, REPORTED IN SEVERAL LEVELS OF CHARGING LEVEL. PATIENT HAS STATED TO HAVE EXPERIENCED THESE ISSUES IN SEVERAL SITUATIONS BEFORE. IT WAS ALSO STATED THAT THERE WERE NO EFFECT OR CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED. INVESTIGATION IS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 855666 | HEARTWARE® VENTRICULAR ASSIST SYSTEM | CIRCULATORY ASSIST SYSTEM | DSQ | HEARTWARE, INC | BAT205868 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | BATTERY-BAT205873 |