BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 18811775 · Received February 29, 2024

    Report

    Report Number
    2916596-2024-01033
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    December 8, 2023
    Report Date
    June 13, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D1: BRAND NAME HAS BEEN CORRECTED. SECTION D4: UDI HAS BEEN CORRECTED. SECTION D4: CATALOG NUMBER HAS BEEN CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE PATIENT FEELING A PINCHING/SHOCKING SENSATION WAS NOT CONFIRMED. THE PROVIDED LOG FILE CONTAINED DATA SPANNING APPROXIMATELY 1 DAY (11FEB2024 ¿ 12FEB2024 PER TIMESTAMP). THE PUMP OPERATED AT INTENDED SPEEDS WHILE CONNECTED TO THE DRIVELINE, AND NO ATYPICAL EVENTS WERE OBSERVED. THE MODULAR CABLE (LOT NUMBER 6890438) WAS NOT RETURNED FOR ANALYSIS. QUESTIONS REGARDING THE CAUSE OF THE EVENT AND IF THE SHOCKING HAD RESOLVED WERE ASKED MULTIPLE TIMES; HOWEVER, RESPONSES TO THESE QUESTIONS WERE NOT RECEIVED. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOR THE MODULAR CABLE, LOT NUMBER 6890438, SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE 3 PATIENT HANDBOOK (SECTION 2 ¿HOW YOUR HEART PUMP WORKS,¿ SECTION 3 ¿POWERING THE SYSTEM,¿ SECTION 4 ¿LIVING WITH THE HEARTMATE 3,¿ AND SECTION 6 ¿CARING FOR THE EQUIPMENT¿) INSTRUCTS THE USER ON HOW TO PROPERLY MAINTAIN THEIR EQUIPMENT, INCLUDING THE MODULAR CABLE, IN SUCH WAYS THAT WOULD AVOID THE USER FEELING AN ELECTRICAL SHOCK. THE HEARTMATE 3 PATIENT HANDBOOK (SECTION TITLED "EMERGENCY CONTACT LIST") CAUTIONS 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IN CLINIC AND STATED THAT THEY FELT ¿PINCHING¿ AT THE DRIVELINE WHERE IT INSERTS TO THE SYSTEM CONTROLLER. THE PATIENT STATED THEY ONLY FELT IT WHEN THE CONTROLLER WAS NEAR THEIR SKIN AND NOT THROUGH CLOTHING, AND THAT IT'S ALMOST LIKE ¿SHOCKS¿. THE PATIENT HAD A CAR ACCIDENT ON (B)(6) 2023 IN WHICH THEY WERE T BONED. THEY DID NOT REMEMBER ANYTHING SPECIFIC HAPPENING TO THEIR DRIVELINE OR CONTROLLER BUT STARTED FEELING THE PINCHING SINCE THEN. LOG FILE REVIEW WAS REQUESTED, AND THE EVENT LOG FILE CAPTURED MULTIPLE PULSATILITY INDEX (PI) EVENTS THAT OCCURRED ON 11FEB2024 FROM 3:59:50 TO 12FEB2024 9:11:37. IT WAS ADDITIONALLY COMMUNICATED ON (B)(6) 2024 THAT THERE WAS NO DAMAGE TO THE DRIVELINE PORTION, MODULAR CABLE OR SYSTEM CONTROLLER CONNECTION, AND THAT THE PUMP AND CONTROLLER WERE WORKING AS EXPECTED. NO TROUBLESHOOTING WAS PERFORMED, AND THE PINCHING RESOLVED. ASSOCIATED MFR# PUMP 2916596-2024-01031 ASSOCIATED MFR# CONTROLER 2916596-2024-01032

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163777 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525 6890438 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male