BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 18335872 · Received December 15, 2023

    Report

    Report Number
    2916596-2023-08378
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 27, 2023
    Report Date
    June 5, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D1 BRAND NAME: CORRECTED , SECTION D4 MODEL NUMBER: CORRECTED, SECTION D4 CATALOG NUMBER: CORRECTED, SECTION D4 EXPIRATION DATE: CORRECTED, SECTION D4 PRIMARY UDI NUMBER: CORRECTED. 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 A DRIVELINE POWER FAULT ALARM WAS CONFIRMED DURING EVALUATION OF THE SUBMITTED LOG FILES. THE SUBMITTED EVENT LOG FILE FROM (B)(6) CONTAINED APPROXIMATELY 7 DAYS OF DATA ((B)(6) 2023 TO (B)(6) 2023 PER TIMESTAMP). BEGINNING AT 11:17:46 ON (B)(6) 2023, A DRIVELINE POWER FAULT ALARM WAS OBSERVED TO BE ACTIVE. THE ACTIVATION OF THIS ALARM COINCIDED WITH PWR_A_BROKEN FAULTS. ALTHOUGH THE FAULTS INTERMITTENTLY CLEARED, THE ALARM LATCHED AND REMAINED ACTIVE THROUGHOUT THE REMAINDER OF THE DATA. THE OBSERVED ALARM AND FAULTS DID NOT IMPACT THE ABILITY OF THE CONTROLLER TO OPERATE THE PUMP, AS THE PUMP MAINTAINED A SPEED ABOVE THE LOW-SPEED LIMIT THROUGHOUT THE DATA. PROVIDED INFORMATION INDICATED THAT THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) AND MODULAR CABLE (LOT NUMBER: 190296) WERE EXCHANGED IN ORDER TO RESOLVE THE ALARM. NO PRODUCTS WERE RETURNED TO ABBOTT FOR ANALYSIS. ADDITIONAL LOG FILES WERE SUBMITTED FROM THE PATIENT¿S NEW CONTROLLER, (B)(6) THE LOG FILE FROM THE NEW CONTROLLER CONTAINED APPROXIMATELY 20 MINUTES OF PATIENT USE ON (B)(6) 2023 (14:22 TO 14:42 PER TIMESTAMP). THE CONTROLLER APPEARED TO BE OPERATING AS INTENDED AND NO FURTHER INTERRUPTIONS IN THE POWER A SIGNAL WERE OBSERVED. THE ROOT CAUSE OF THE OBSERVED DRIVELINE POWER FAULT ALARM COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 PATIENT HANDBOOK (REV. D - SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿) COVERS ALL ALARMS (VISUAL AND AUDIBLE) THAT ARE ASSOCIATED WITH THE SYSTEM CONTROLLER, INCLUDING DRIVELINE POWER FAULT, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. THE HEARTMATE 3 PATIENT HANDBOOK (REV. D - SECTION 6 ¿CARING FOR THE EQUIPMENT¿) DESCRIBES HOW TO PROPERLY CARE FOR AND CLEAN ALL EQUIPMENT, INCLUDING THE MODULAR CABLE. THE PATIENT HANDBOOK CAUTIONS THE USER 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. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THE RECORDS REVEALED THAT THE MODULAR CABLE (LOT NUMBER: 190296) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. 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 COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LOG FILES WERE SUBMITTED DUE TO DRIVELINE POWER FAULT ALARM PRESENT. THE LOG FILES CONFIRMED A DRIVELINE POWER A FAULT ON 27NOV2023. THE LOG FILE ALSO CAPTURED A NO EXTERNAL POWER EVENT ON 21NOV2023. THIS WAS CAUSED BY POWER TO THE MOBILE POWER UNIT (MPU) BEING BRIEFLY INTERRUPTED. THE SYSTEM CONTROLLER AND MODULAR CABLE WERE REPLACED. FOLLOWING THE EXCHANGE, THERE WERE NO UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. ADDITIONAL INFORMATION STATED THAT LOG FILES WERE SENT INTO ABBOTT AND ALARMS WERE MANUALLY CLEARED. FOLLOWING THE CONTROLLER EXCHANGE THERE WERE NO UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. RELATED CONTROLLER WAS REPORTED UNDER MANUFACTURER REPORT NUMBER 2916596-2023-08376. RELATED MPU WAS REPORTED UNDER MANUFACTURER REPORT NUMBER 2916596-2023-08377.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2268468 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 190296 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male