BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 19977541 · Received August 13, 2024

    Report

    Report Number
    2916596-2024-05123
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 26, 2024
    Report Date
    December 27, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION H6: MEDICAL DEVICE PROBLEM CODE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE FAULT ALARM WAS CONFIRMED VIA THE SUBMITTED LOG FILES BUT WAS NOT REPRODUCED DURING EVALUATION OF THE RETURNED MODULAR CABLE. THE SLIGHT BEND IN THE MODULAR CABLE WAS CONFIRMED ON THE RETURNED MODULAR CABLE. ON (B)(6) 2024 AT 00:01:28, THE LOG FILE CAPTURED DRIVELINE POWER FAULT ALARMS DUE TO POWER A OPEN FAULTS. THE POWER A OPEN FAULTS ARE DUE TO THE CURRENT SENSE INTERMITTENTLY DROPPING BELOW THE THRESHOLD. THE DRIVELINE POWER FAULT ALARM REMAINED ACTIVE UNTIL THE DRIVELINE WAS DISCONNECTED AT 09:38:47. THIS IS CONSISTENT WITH THE EXCHANGE OF THE SYSTEM CONTROLLER. THE DRIVELINE POWER FAULT ALARMS DID NOT IMPACT THE SYSTEM CONTROLLER¿S ABILITY TO SUPPORT THE PUMP AND THERE WERE NO OTHER NOTABLE EVENTS CAPTURED ON THE REPORTED EVENT DATE IN THE LOG FILE. ADDITIONAL SUBMITTED LOG FILES CONTAINING DATA FROM AFTER THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED WERE REVIEWED AND SHOWED THE SYSTEM FUNCTIONING AS INTENDED. THE MODULAR CABLE WAS FUNCTIONALLY TESTED WITH THE RETURNED HEARTMATE 3 SYSTEM CONTROLLER, SERIAL NUMBER: (B)(6), ON A MOCK CIRCULATORY LOOP FOR AN EXTENDED OPERATION DURING WHICH THE CABLE WAS MANIPULATED BY HAND. NO ATYPICAL ALARMS WERE REPRODUCED. DISCOLORATION ON THE BEND RELIEFS OF THE MODULAR CABLE AND A SLIGHT BEND NEAR THE INLINE CONNECTOR BEND RELIEF WAS OBSERVED. FOLLOWING THE ELECTRICAL TESTING AND OPERATION OF THE MODULAR CABLE ON THE MOCK CIRCULATORY LOOP, THE CABLE¿S PROTECTIVE LAYERS WERE CAREFULLY REMOVED TO INSPECT THE UNDERLYING WIRES AND NO ISSUES WERE OF OBSERVED. THE PROVIDED INFORMATION INDICATED NO FURTHER ALARMS HAVE BEEN OBSERVED SINCE THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED. A ROOT CAUSE FOR THE REPORTED EVENT WAS NOT CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALS THAT THE MODULAR CABLE, LOT NUMBER: 8371302, WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE 3 INSTRUCTIONS FOR USE (REV. A) WAS AVAILABLE FOR USE AT THE TIME OF THE EVENT. SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ PROVIDES INSTRUCTION ON HOW TO IDENTIFY AND TROUBLESHOOT ALL ALARMS, INCLUDING DRIVELINE POWER FAULT ALARMS. THE HEARTMATE 3 INSTRUCTIONS FOR USE, SECTION 5, ENTITLED ¿SURGICAL PROCEDURES¿ AND SECTION 6, ENTITLED ¿PATIENT CARE AND MANAGEMENT¿ CAUTION USER TO AVOID TWISTS, KINKS, OR SHARP BENDS IN THE DRIVELINE. THE HEARTMATE 3 INSTRUCTIONS FOR USE, SECTION D, ENTITLED ¿SAFETY CHECKLISTS¿ INSTRUCTS USERS TO INSPECT THE DRIVELINE FOR DAMAGE DAILY. THE HEARTMATE 3 PATIENT HANDBOOK (REV. D) WHICH WAS AVAILABLE FOR USE AT THE TIME OF THE EVENT, CAUTIONS THE 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE FAULT ALARM WAS CONFIRMED VIA THE SUBMITTED LOG FILES BUT WAS NOT REPRODUCED DURING EVALUATION OF THE RETURNED MODULAR CABLE. THE SLIGHT BEND IN THE MODULAR CABLE WAS CONFIRMED ON THE RETURNED MODULAR CABLE. ON 26JUL2024 AT 00:01:28, THE LOG FILE CAPTURED DRIVELINE POWER FAULT ALARMS DUE TO POWER A OPEN FAULTS. THE POWER A OPEN FAULTS ARE DUE TO THE CURRENT SENSE INTERMITTENTLY DROPPING BELOW THE THRESHOLD. THE DRIVELINE POWER FAULT ALARM REMAINED ACTIVE UNTIL THE DRIVELINE WAS DISCONNECTED AT 09:38:47. THIS IS CONSISTENT WITH THE EXCHANGE OF THE SYSTEM CONTROLLER. THE DRIVELINE POWER FAULT ALARMS DID NOT IMPACT THE SYSTEM CONTROLLER¿S ABILITY TO SUPPORT THE PUMP AND THERE WERE NO OTHER NOTABLE EVENTS CAPTURED ON THE REPORTED EVENT DATE IN THE LOG FILE. ADDITIONAL SUBMITTED LOG FILES CONTAINING DATA FROM AFTER THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED WERE REVIEWED AND SHOWED THE SYSTEM FUNCTIONING AS INTENDED. THE RETURNED MODULAR CABLE, 8993378, WAS FUNCTIONALLY TESTED WITH THE RETURNED HEARTMATE 3 SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), ON A MOCK CIRCULATORY LOOP FOR AN EXTENDED OPERATION DURING WHICH THE CABLE WAS MANIPULATED BY HAND. NO ATYPICAL ALARMS WERE REPRODUCED. DISCOLORATION ON THE BEND RELIEFS OF THE MODULAR CABLE AND A SLIGHT BEND NEAR THE INLINE CONNECTOR BEND RELIEF WAS OBSERVED. FOLLOWING THE ELECTRICAL TESTING AND OPERATION OF THE MODULAR CABLE ON THE MOCK CIRCULATORY LOOP, THE CABLE¿S PROTECTIVE LAYERS WERE CAREFULLY REMOVED TO INSPECT THE UNDERLYING WIRES AND NO ISSUES WERE OF OBSERVED. THE PROVIDED INFORMATION INDICATED NO FURTHER ALARMS HAVE BEEN OBSERVED SINCE THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED. A ROOT CAUSE FOR THE REPORTED EVENT WAS NOT CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALS THAT THE MODULAR CABLE, LOT NUMBER 8993378, WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE 3 INSTRUCTIONS FOR USE (REV. A) WAS AVAILABLE FOR USE AT THE TIME OF THE EVENT. SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ PROVIDES INSTRUCTION ON HOW TO IDENTIFY AND TROUBLESHOOT ALL ALARMS, INCLUDING DRIVELINE POWER FAULT ALARMS. THE HEARTMATE 3 INSTRUCTIONS FOR USE, SECTION 5, ENTITLED ¿SURGICAL PROCEDURES¿ AND SECTION 6, ENTITLED ¿PATIENT CARE AND MANAGEMENT¿ CAUTION USER TO AVOID TWISTS, KINKS, OR SHARP BENDS IN THE DRIVELINE. THE HEARTMATE 3 INSTRUCTIONS FOR USE, SECTION D, ENTITLED ¿SAFETY CHECKLISTS¿ INSTRUCTS USERS TO INSPECT THE DRIVELINE FOR DAMAGE DAILY. THE HEARTMATE 3 PATIENT HANDBOOK (REV. D) WHICH WAS AVAILABLE FOR USE AT THE TIME OF THE EVENT, CAUTIONS THE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A DRIVELINE FAULT ALARM AT 0001 ON (B)(6) 2024. THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF THE ALARM AND THERE WAS NO LOSS OF POWER OR FLOW. IT WAS RECOMMENDED BY ABBOTT THAT THE PATIENT PRESENT TO THE EMERGENCY DEPARTMENT FOR LEFT VENTRICULAR ASSIST DEVICE (LVAD) INTERROGATION AND ASSESSMENT. THERE WAS NO EXTERNAL DAMAGE TO THE DRIVELINE OTHER THAN A SLIGHT PERMANENT BEND TO THE MODULAR CABLE PROXIMAL TO THE PATIENT, BUT NO WIRES WERE SHOWING AND NO DAMAGE TO THE SHEATH. LOG FILES WERE SUBMITTED FOR REVIEW AND CONFIRMED THE DRIVELINE POWER (A) FAULTS ON (B)(6) 2024. A MODULAR CABLE AND SYSTEM CONTROLLER EXCHANGE WAS RECOMMENDED. THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED, AND THE ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094092 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 8993378 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male