BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE POWER MODULE PATIENT CABLE, 14 VOLT

    MDR report key: 12072728 · Received June 26, 2021

    Report

    Report Number
    2916596-2021-03092
    Event Type
    Malfunction
    Date Received
    June 26, 2021
    Date of Event
    March 22, 2021
    Report Date
    June 26, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURES INVESTIGATION CONCLUSION: THE REPORTED EVENT OF LOW VOLTAGE ALARMS WAS CONFIRMED BASED ON THE INFORMATION CONTAINED IN THE PROVIDED LOG FILES. TWO LOG FILES PROVIDED BY THE CUSTOMER WERE REVIEWED. THE FIRST LOG FILE CONTAINED EVENTS RECORDED FROM (B)(6) TO (B)(6) 2021 WHERE MULTIPLE LOW VOLTAGE ALARMS WERE RECORDED. THE ASSOCIATED VOLTAGE LEVELS SUGGESTED THAT THESE ALARMS OCCURRED WHILE THE SYSTEM CONTROLLER WAS CONNECTED TO A POWER MODULE AND MAY INDICATED A POSSIBLE INNER CONDUCTOR BREAKDOWN IN THE POWER MODULE PATIENT CABLE. THE SECOND LOG FILE CONTAINED EVENTS RECORDED FROM (B)(6) TO (B)(6) 2021. THE VOLTAGE LEVELS RECORDED ON (B)(6) INDICATED THAT THE SYSTEM CONTROLLER WAS CONNECTED TO A MPU AND THE SYSTEM OPERATED WITH NO LOW VOLTAGE ALARMS UNTIL (B)(6) WHEN AT 12:07 AM THERE WAS A BRIEF NO EXTERNAL POWER/LOW VOLTAGE HAZARD ALARM ASSOCIATED WITH THE MPU POWER BEING LOST. DURING THIS EVENT THE SYSTEM WAS SUPPORTED BY THE CONTROLLER¿S BACKUP BATTERY. THERE WAS A SECOND INCIDENT WHERE THE POWER TO THE MPU WAS LOST RECORDED ON (B)(6) AT 11:42 AM. DURING THIS EVENT THE SYSTEM CONTROLLER ACTIVATED A NO EXTERNAL POWER/ LOW VOLTAGE HAZARD ALARM AND THE SYSTEM OPERATED POWERED BY THE INTERNAL BACKUP BATTERY. THE REMAINING DATA CAPTURED IN THE LOG FILE REVEALED NORMAL VOLTAGE LEVELS. THE LOW VOLTAGE ALARMS CAPTURED IN THE LOG FILE MAY SUGGEST A POSSIBLE CONDUCTOR BREAKDOWN IN THE POWER MODULE PATIENT CABLE; HOWEVER, THE POWER MODULE PATIENT CABLE WAS NOT RETURNED FOR EVALUATION AND A SPECIFIC ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND THE STATUS OF THE DEVICES WERE SENT; HOWEVER, THE ADDITIONAL INFORMATION WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD RARE NO EXTERNAL POWER ALARMS AND RECENTLY HAD THEIR OLD POWER MODULE (PPU) REPLACED WITH A NEW MOBILE POWER UNIT (MPU). THE PATIENT IS A POOR HISTORIAN AND IT IS DIFFICULT TO FULLY UNDERSTAND IF SHE WAS DISCONNECTING BOTH POWER SOURCES OR PULLING MPU OUT OF OUTLET. THE PATIENT IS CURRENTLY INPATIENT AND UNDERGOING A COSMETIC REPAIR OF THEIR HEARTMATE 2 DRIVELINE. PATIENT ALSO UNDERWENT LOW VOLTAGE ALARMS THAT WERE PRESUMED TO BE CAUSED BY CABLE FATIGUE FROM POWER MODULE. LOG FILE SUBMITTED CONTAINED 2 ADDITIONAL LOSS OF EXTERNAL POWER EVENTS AFTER THE PPM TO MPU SWAP. THE EVENT ON (B)(6) 2021 AT 12:17AM APPEARS TO INDICATE THE MPU MAY HAVE LOST AC POWER FOR ~1 SECOND. THE SECOND EVENT ON (B)(6) 2021 AT 11:42AM APPEARS TO INDICATE THE PATIENT MAY HAVE BEEN SWAPPING TO BATTERY POWER AND ACCIDENTLY DISCONNECTED BOTH CONTROLLER LEADS FROM MPU POWER AT THE SAME TIME. THE EVENT DURATION OF THE SECOND EVENT APPEARS TO BE ~14 SECONDS. THE CONTROLLER DID SWITCH APPROPRIATELY TO EBB POWER DURING THESE EVENTS. THESE EVENTS APPEAR TO RESOLVE ONCE POWER WAS COMPLETELY RESTORED TO THE CONTROLLER. THESE TYPES EVENTS CAN BE CAUSED BY AC POWER OUTAGES, FAULTY HOME POWER OUTLET, OR BY POOR MPU AC CONNECTION, AND IN SOME CASES PATIENT ERROR. RELATED MANUFACTURER'S REPORT NUMBER: 2916596-2021-01746, 2916596-2021-01928.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969456 HEARTMATE POWER MODULE PATIENT CABLE, 14 VOLT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 103426

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR