THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
Report
- Report Number
- 2916596-2025-03139
- Event Type
- Malfunction
- Date Received
- May 29, 2025
- Date of Event
- May 3, 2025
- Report Date
- July 8, 2025
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024013297
- PMA / PMN Number
- P160054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
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.
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
SECTION E1: REPORTER EMAIL WAS NOT AVAILABLE. SECTION H6: CLINICAL CODE CORRECTED MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED A PUMP STOP ASSOCIATED WITH A DRIVELINE DISCONNECT; HOWEVER, A SPECIFIC CAUSE FOR THE DRIVELINE DISCONNECT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. FURTHER, A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED RENAL DYSFUNCTION, INFECTION, AND HEART FAILURE EXACERBATION COULD NOT BE CONCLUSIVELY ESTABLISHED. THE CONTROLLER EVENT LOG FILE CONTAINED EVENTS FROM 28APR2025 THROUGH 04MAY2025. ON 03MAY2025, THE DRIVELINE WAS DISCONNECTED CAUSING THE PUMP TO STOP. THIS PUMP STOP EVENT WAS ASSOCIATED WITH DRIVELINE DISCONNECT, LEFT VENTRICULAR ASSIST DEVICE (LVAD) OFF, AND LOW FLOW HAZARD ALARMS. FOLLOWING THE RECONNECTION OF THE DRIVELINE, THE PUMP RESUMED OPERATION AT THE FIXED SPEED WITHOUT ISSUE. THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE FIXED SPEED WHILE THE DRIVELINE WAS CONNECTED. THE PATIENT¿S LACTATE DEHYDROGENASE WAS UNIMPRESSIVE, AND THE ACCOUNT COMMUNICATED THAT THE PATIENT LIKELY DID NOT HAVE HEMOLYSIS. NO EQUIPMENT WAS EXCHANGED, AND THE DRIVELINE DISCONNECTS REPORTEDLY RESOLVED AS THERE WAS NO DOCUMENTATION OF CONTINUED DRIVELINE DISCONNECT EVENTS. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), WITH NO FURTHER EVENTS 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 CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) IFUAND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RENAL DYSFUNCTION AND INFECTION (LOCAL, DRIVELINE, AND PUMP POCKET), THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 2 OF THE IFU, "SYSTEM OPERATIONS" (UNDER "SYSTEM CONTROLLER WARNINGS AND CAUTIONS"), AND SECTION 2 OF THE PATIENT HANDBOOK, ¿HOW YOUR HEART PUMP WORKS¿, INSTRUCT THE USER TO CHECK THE SYSTEM CONTROLLER DRIVELINE CONNECTOR TO CONFIRM THAT THE DRIVELINE IS SECURELY INSERTED IN THE SOCKET. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, THE PUMP STOPS. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, PROMPTLY RECONNECT IT TO RESUME PUMP OPERATION. THE PATIENT HANDBOOK FURTHER EXPLAINS THAT THE PUMP CANNOT RUN WITHOUT POWER. SECTION 2 OF THE IFU ALSO CONTAINS A SECTION TITLED "CONNECTING THE DRIVELINE TO THE SYSTEM CONTROLLER", WHICH PROVIDES INSTRUCTIONS ON CONNECTING/DISCONNECTING THE DRIVELINE TO/FROM THE SYSTEM CONTROLLER AND MAKING SURE THAT IT IS FULLY AND PROPERLY INSERTED INTO THE SYSTEM CONTROLLER SOCKET. SECTION 6 OF THE IFU, UNDER "EDUCATING AND TRAINING PATIENTS, FAMILIES, AND CAREGIVERS", EXPLAINS THAT DURING THE PATIENT SELECTION, PREIMPLANT, AND POSTOPERATIVE PERIOD, THE PATIENT MUST RECEIVE INSTRUCTIONS REGARDING THE OPERATION AND CARE OF EVERY SYSTEM COMPONENT (INCLUDING THE DRIVELINE AND WHAT TO DO IN AN EMERGENCY). THIS SECTION ALSO PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INR RANGE. ADDITIONALLY, SECTION 6 OF THE IFU LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. FURTHERMORE, SEVERAL SECTIONS OF THE HM3 IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, DESCRIBE ALL ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. THE PATIENT HANDBOOK ALSO CONTAINS A SECTION ON HANDLING EMERGENCIES AND FURTHER INSTRUCTS THE USER TO CALL THEIR HOSPITAL CONTACT IF THE USER THINKS, FOR ANY REASON, ANY PORTION OF THE EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THE USER IS UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
THE PATIENT HAD ACUTE KIDNEY INJURY ON CHRONIC KIDNEY DISEASE II WITH HYPERKALEMIA, ACUTE ON CHRONIC SYSTOLIC HEART FAILURE EXACERBATION AND SUSPECTED ABDOMINAL WALL INFECTION. CELLULITIS WAS TREATED WITH ANTIBIOTICS. FOR THE SUPRA THERAPEUTIC INR IT WAS NOTED THAT THE PATIENT DENIED ANY MEDICATION CHANGES, DIET CHANGES, OR WARFARIN DOSE CHANGES. WARFARIN WAS HELD AND WAS GIVEN VITAMIN KX 1 WITH IMPROVEMENT IN THE INR. ACUTE DECOMPENSATED HEART FAILURE (ADHF) WAS TREATED WITH INTRAVENOUS BUMEX. HYPERKALEMIA WAS TREATED WITH LOKELMA. THE ABDOMINAL PAIN AND SUPRATHERAPEUTIC INR RESOLVED.
THE LDH WAS UNIMPRESSIVE SO IT WAS NOT LIKELY HEMOLYSIS. THERE WAS ACUTE KIDNEY INJURY (AKI) SUSPECTED WITH UNDERLYING CHRONIC KIDNEY DISEASE AND ARB , KCI. THE STATUS POST SHIFT MEDS AND LOKELMA WAS MAKING URINE WITH A GOOD RESPONSE TO LOOP DIURETIC. IT WAS HOPEFUL HYPERKALEMIA WOULD IMPROVE SOON. IF IT DID NOT IMPROVE IN THE NEXT FEW HOURS RENAL REPLACEMENT THERAPY WOULD NEED TO BE DONE. ONSET OF AKI CAPTURED UNDER MFR # 2916596-2025-04422.
IT WAS REPORTED THAT THERE APPEARED TO BE A DRIVELINE DISCONNECT FOLLOWED BY A PUMP OFF EVENT. THE LOG FILES WERE REVIEWED AND CAPTURED A DRIVELINE DISCONNECT EVENT ON 03MAY2025. THE EVENT LASTED APPROXIMATELY 7 SECONDS. THE PUMP RESUMED AT THE SET SPEED AFTER THE DRIVELINE WAS RECONNECTED. THE PUMP APPEARED TO BE FUNCTIONING AS INTENDED. THE CAUSE OF THE DRIVELINE DISCONNECT WAS UNKNOWN. DOCUMENTATION WAS FOUND STATING THAT THE PATIENT WAS UNAWARE OR UNSURE HOW IT HAPPENED. THE PATIENT WAS CURRENTLY STABLE, OUTPATIENT. THE PATIENT WAS ADMITTED ON (B)(6) 2025 WITH ABDOMINAL PAIN AND SUPRA THERAPEUTIC INTERNAL NORMALIZED RATIO (INR). THERE WAS NO EQUIPMENT EXCHANGED. THE DRIVELINE DISCONNECT RESOLVED WITH NO DOCUMENTATION OF CONTINUED DRIVELINE DISCONNECT EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 625755 | THORATEC® HEARTMATE 3® LVAS IMPLANT KIT | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106524US | 7142010 | 00813024013297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Male | Hospitalization| R |