HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
Report
- Report Number
- 2916596-2014-00699
- Event Type
- Injury
- Date Received
- May 15, 2014
- Date of Event
- April 15, 2014
- Report Date
- April 15, 2014
- Manufacturer
- THORATEC CORP.
- Product Code
- DSQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
THE LVAD WAS RETURNED TO THE MFR FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED
THE REPORT OF LOW SPEED EVENTS WAS CONFIRMED THROUGH EVALUATION OF THE SUBMITTED SYSTEM CONTROLLER LOG FILES; HOWEVER THE PERCUTANEOUS LEAD (LEAD) WIRE DAMAGE COULD NOT CONCLUSIVELY BE CONFIRMED WITHOUT AN EVALUATION OF THE ENTIRE LEAD. THE PUMP WAS RECEIVED FOR ANALYSIS ON (B)(6) 2014. THE PUMP WAS RETURNED ASSEMBLED WITH THE LEAD CUT APPROXIMATELY 0.25¿ FROM THE PUMP HOUSING AND THE DISTAL PORTION OF THE LEAD WAS NOT RETURNED. THE SEALED INFLOW CONDUIT (INLET TUBE, FLEX SECTION, AND INLET ELBOW) WAS RETURNED ATTACHED TO THE PUMP¿S INLET PORT. THE SEALED OUTFLOW GRAFT, OUTFLOW GRAFT BEND RELIEF, AND OUTFLOW GRAFT BEND RELIEF COLLAR WERE RETURNED ATTACHED TO THE PUMP¿S OUTLET PORT. VISUAL EXAMINATION OF THE SEALED OUTFLOW GRAFT, AND SEALED INFLOW CONDUIT REVEALED NO EVIDENCE OF THROMBUS FORMATIONS OR DEPOSITIONS. VISUAL EXAMINATION OF THE PUMP¿S BLOOD-CONTACTING SURFACES UPON DISASSEMBLY REVEALED NO EVIDENCE OF DEPOSITIONS OR THROMBUS FORMATIONS. THE DISASSEMBLED PUMP¿S BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES WERE EXAMINED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED. ELECTRICAL CONTINUITY TESTING OF THE RETURNED PORTION OF THE LEAD DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. THE PUMP WAS CLEANED, REASSEMBLED AND FUNCTIONALLY TESTED UNDER NORMAL OPERATING CONDITIONS USING A MOCK CIRCULATORY LOOP. THE DATA RETRIEVED FROM THAT TESTING REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES, COMPARABLE TO WHAT WAS RECORDED DURING THE MANUFACTURING PROCESS AND THE DEVICE FUNCTIONED AS INTENDED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.
THE USER FACILITY MEDWATCH REPORT WAS RECEIVED FROM THE (B)(4) REGISTRY. THE USER FACILITY NUMBER WAS NOT PROVIDED. (B)(4).
ADDITIONAL INFORMATION WAS RECEIVED FROM THE (B)(4) REGISTRY STATING: PUMP ALARMS AT HOME. "BEEPING WHEN SHE CONNECTS TO AC POWER" ANALYSIS VIA LOGFILES, TESTING AND XRAY INDICATED DRIVELINE FRACTURE INTERNALLY. URGENT TRANSPLANT.
THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT CALLED THE OFFICE REPORTING YELLOW AND GREEN LIGHTS ON HER SYSTEM CONTROLLER WITH BEEPING. THIS ONLY HAPPENED WHILE SHE WAS CONNECTED TO THE POWER MODULE PT CABLE. THE HOSPITAL CHANGED OUT THE PT'S POWER MODULE PT CABLE. EVENT WITH THIS REPLACED SHE CONTINUED TO HAVE THE BEEPS. THE PT EXCHANGED SYSTEM CONTROLLERS. SHE REPORTED HAVING ANOTHER BEEP WHILE CONNECTED TO THE POWER MODULE. THE HOSPITAL INTERROGATED HER PUMP. THEY SAW SHE WAS HAVING SPEED DROPS AT TIMES. THE HOSPITAL SUSPECTS AN INTERNAL DRIVELINE BREAK. X-RAYS SHOWED AN AREA OF SUSPICION INTERNALLY THE PT IS LISTED AS 1A ON THE TRANSPLANT LIST. THE PT WAS TRANSPLANTED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291569 | HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE | DSQL LEFT VENTRICULAR ASSIST DEVICE | DSQ | THORATEC CORP. | 104911 | 122807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |