BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE POWER MODULE

    MDR report key: 17654193 · Received August 30, 2023

    Report

    Report Number
    2916596-2023-06287
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    August 10, 2023
    Report Date
    November 16, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010654
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED MFR 2916596-2023-06452. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THE PMA# P160054 PROVIDED IS ASSOCIATED WITH MOST RECENT APPROVAL. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DAMAGE TO THE INTERNAL BATTERY CLIP WAS CONFIRMED UPON ARRIVAL OF THE RETURNED PRODUCT. PROVIDED INFORMATION INDICATED THAT THERE WAS NO PATIENT ASSOCIATED WITH THIS COMPLAINT, AND NO POWER MODULE ALARMS ASSOCIATED WITH THE DAMAGE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE SERIAL NUMBER OF THE POWER MODULE ASSOCIATED WITH THE INTERNAL BATTERY CLIP; HOWEVER, NO RESPONSE WAS RECEIVED. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED VIA THIS ANALYSIS. THE HEARTMATE POWER MODULE INSTRUCTIONS FOR USE (IFU) INSTRUCTS USERS TO REGULARLY INSPECT THE POWER MODULE, AND TO NOT USE A POWER MODULE THAT APPEARS DAMAGED. THE HEARTMATE POWER MODULE IFU (SECTION 11.0 ¿ROUTINE MAINTENANCE) INSTRUCTS USERS TO BRING THEIR POWER MODULE TO AN AUTHORIZED SERVICE TECHNICIAN AT LEAST ONCE PER YEAR FOR A THOROUGH INSPECTION AND CLEANING. THE HEARTMATE 3 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 FOR THE POWER MODULE COULD NOT BE REVIEWED, AS THE SERIAL NUMBER OF THE ASSOCIATED UNIT WAS NOT PROVIDED. 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 DAMAGE TO THE INTERNAL BATTERY CLIP WAS CONFIRMED UPON ARRIVAL OF THE RETURNED PRODUCT. PROVIDED INFORMATION INDICATED THAT THERE WAS NO PATIENT ASSOCIATED WITH THIS COMPLAINT, AND NO POWER MODULE ALARMS ASSOCIATED WITH THE DAMAGE. THE POWER MODULE SERIAL NUMBER (B)(6) WAS PROVIDED IN RELATION TO THIS EVENT; HOWEVER, IT COULD NOT BE DETERMINED WHICH OF THE TWO RETURNED CLIPS BELONGED TO THAT SPECIFIC POWER MODULE. THE OTHER SERIAL NUMBER IS UNKNOWN. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED VIA THIS ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOR THE POWER MODULE, SERIAL NUMBER (B)(6), SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE POWER MODULE INSTRUCTIONS FOR USE (IFU) (REV. B) INSTRUCTS USERS TO REGULARLY INSPECT THE POWER MODULE, AND TO NOT USE A POWER MODULE THAT APPEARS DAMAGED. THE HEARTMATE POWER MODULE IFU (SECTION 11.0 ¿ROUTINE MAINTENANCE¿) INSTRUCTS USERS TO BRING THEIR POWER MODULE TO AN AUTHORIZED SERVICE TECHNICIAN AT LEAST ONCE PER YEAR FOR A THOROUGH INSPECTION AND CLEANING. THE HEARTMATE 3 PATIENT HANDBOOK (REV. D) 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 SERIAL NUMBER (B)(6) WAS PROVIDED IN RELATION TO THIS EVENT. IT COULD NOT BE DETERMINED WHICH OF THE TWO RETURNED CLIPS BELONGED TO THIS POWER MODULE. THE OTHER SERIAL NUMBER IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO POWER MODULE BATTERY CLIPS WERE RETURNED. ADDITIONAL INFORMATION WAS REPORTED THAT THE CLIPS WERE BROKEN AND EXCHANGED. THERE WAS NO ALARMS OR PATIENTS RELATED TO THIS INCIDENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS COMMUNICATED AND SERIAL NUMBER (B)(6) WAS PROVIDED IN RELATION TO THIS EVENT; HOWEVER, IT COULD NOT BE DETERMINED WHICH OF THE TWO RETURNED CLIPS BELONGED TO THAT SPECIFIC POWER MODULE. THE OTHER SERIAL NUMBER IS UNKNOWN. RELATED MANUFACTURER REPORT NUMBER 2916596-2023-06452.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678842 HEARTMATE POWER MODULE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 1340 00813024010654

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown