THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)
Report
- Report Number
- 2916596-2024-01151
- Event Type
- Malfunction
- Date Received
- March 12, 2024
- Date of Event
- February 16, 2024
- Report Date
- August 29, 2024
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- PMA / PMN Number
- P060040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
PUMP SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
SECTION A4: PATIENT WEIGHT: CORRECTED SECTION D1: BRAND NAME HAS BEEN CORRECTED. SECTION D4: DEVICE EXPIRATION DATE CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS UPDATED WITH ALL OF THE CURRENT INFORMATION AVAILABLE. SECTION D4: CATALOG NUMBER HAS BEEN CORRECTED. SECTION D4: SERIAL NUMBER HAS BEEN CORRECTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
SECTION D4: UDI: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED A DRIVELINE DISCONNECT EVENT THAT RESULTED IN A PUMP STOP, WHICH APPEARED TO BE CONSISTENT WITH THE PATIENT ATTEMPTING TO EXCHANGE THE CONTROLLER. THE SUBMITTED LOG FILE OF THE PRIMARY CONTROLLER CONTAINED EVENTS FROM 04JAN2024 THROUGH 17FEB2024. ON 16FEB2024 AT 20:01:56, THE DRIVELINE WAS DISCONNECTED CAUSING THE PUMP TO STOP. THE DRIVELINE WAS RECONNECTED AT 20:06:52 AND THE PUMP RESUMED NORMAL OPERATION AT THE SET SPEED WITHOUT ISSUE. NO OTHER NOTABLE EVENTS OR ALARMS WERE OBSERVED. THE PUMP APPEARED TO FUNCTION AS INTENDED AND OPERATED ABOVE THE LOW SPEED LIMIT WHILE THE DRIVELINE WAS CONNECTED. THE SUBMITTED LOG FILE OF THE BACKUP CONTROLLER SHOWED THE DRIVELINE WAS NOT CONNECTED TO THE SYSTEM CONTROLLER DURING THE REPORTED TIMEFRAME. THE PATIENT REMAINS ONGOING ON HEARTMATE (HM) II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE II LVAS IFU, REV. C AND THE HEARTMATE II LVAS PATIENT HANDBOOK, REV. C ARE CURRENTLY AVAILABLE. SECTION 2 OF THE IFU ¿HOW YOUR HEART PUMP WORKS,¿ UNDER SUB-SECTION TITLED "CONNECTING THE DRIVELINE TO THE SYSTEM CONTROLLER," ADDRESSES THE PROPER STEPS FOR CONNECTING THE DRIVELINE TO THE SYSTEM CONTROLLER. IT ALSO STATES TO CHECK THE SYSTEM CONTROLLER DRIVELINE CONNECTOR OFTEN TO CONFIRM THAT THE DRIVELINE IS SECURELY INSERTED IN THE SOCKET. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, THE PUMP WILL STOP. SECTION 7 OF THE IFU AND SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, ADDRESS ALL ALARM CONDITIONS, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. THE PATIENT HANDBOOK ALSO CAUTION USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
IT WAS REPORTED THAT THE PRIMARY SYSTEM CONTROLLER APPEARED TO HAVE BEEN WITHOUT POWER FOR 6 MINUTES ON 16 FEB 2024. THE PATIENT PRESENTED TO AN OUTSIDE HOSPITAL EMERGENCY ROOM AT 1830 ON 16 FEB 2024, AND THE SITE STATED THAT THE OUTSIDE HOSPITAL ATTEMPTED TO PERFORM A CONTROLLER EXCHANGE TO THE PATIENT'S BACKUP. LOG FILE REVIEW WAS REQUESTED AND CONTAINED ALARMS ASSOCIATED WITH A LOSS OF EXTERNAL POWER EVENT. THE PATIENT APPEARED TO HAVE BEEN UTILIZING BATTERY POWER ON 16 FEB 2024 AND DEPLETED BOTH BATTERIES. DURING THE EVENT, THE CONTROLLER DID SWITCH APPROPRIATELY TO THE BACKUP BATTERY (BB). WHILE IN BB MODE THE LOG FILE INDICATED THE DRIVELINE WAS BRIEFLY DISCONNECTED AND RECONNECTED CAUSING THE PUMP STOP EVENTS. THE EVENT ALARMS APPEARED TO RESOLVE ONCE EXTERNAL POWER WAS RECONNECTED. THE PUMP THEN RESUMED NORMAL OPERATION. TECHNICAL SERVICES NOTED THAT THE PATIENT DID NOT APPEAR TO HAVE BEEN SWAPPED OVER TO THE BACKUP CONTROLLER AS THAT FILE DID NOT SHOW ANY PUMP CONNECTION SINCE 2017. IT WAS ALSO NOTED THAT THE PATIENT APPEARED TO BE SLEEPING ON BATTERY POWER WHICH WAS NOT RECOMMENDED. ACCORDING TO THE PATIENT, THE NO EXTERNAL POWER (NEP) EVENT WAS DUE TO THEIR BATTERIES BEING DRAINED. IT WAS ALSO NOTED BY THE PATIENT THAT THE REASON FOR THE DRIVELINE BEING DISCONNECTED AND RECONNECTED WAS BECAUSE THEIR BATTERIES WERE DRAINED. THE SITE NOTED THAT THE CAUSE OF THE NEP EVENT AND THE DISCONNECTION OF THE DRIVELINE WERE ALL HEAR-SAY. THE PATIENT DID NOT HAVE ANY ADVERSE CONSEQUENCES/SYMPTOMS DURING THE PUMP STOP. THE SITE NOTED THAT THEY WERE OBSERVED AT THE HOSPITAL AND THE PATIENT WAS FINE. IT WAS UNKNOWN WHY THE CONTROLLER WAS BEING CHANGED. RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). (CONTROLLER)
IT WAS ADDITIONALLY COMMUNICATED ON 01JUL2024 THAT THE DECISION TO EXCHANGE THE CONTROLLER WAS MADE BY THE PATIENT INDEPENDENTLY. THE SITE WAS TOLD THAT THEY EXCHANGED IT BECAUSE THEIR PUMP STOPPED AFTER DEPLETING ALL THEIR EXTERNAL POWER AND THE PRIMARY CONTROLLER AND THE PATIENT FELT THE BACKUP CONTROLLER WOULD GIVE THEM MORE POWER. THE COORDINATOR TEAM WAS NOT PART OF THE DECISION. THEY ADDITIONALLY STATED THAT THEY WERE NOT SURE HOW LONG THE PATIENT WAS WITHOUT POWER BUT ACCORDING TO THE COMMUNITY HOSPITAL, THEY WERE GRAY IN COLOR, SO IT WAS FELT THAT THEIR PUMP DID STOP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1370651 | THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 107801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male |