BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE® POWER MODULE (N/A)

    MDR report key: 19922947 · Received August 6, 2024

    Report

    Report Number
    2916596-2024-04953
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 18, 2024
    Report Date
    October 17, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010654
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1 - A4: PATIENT INFORMATION NOT PROVIDED SECTION D4: EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION G4: THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THE PMA# PROVIDED IS ASSOCIATED WITH MOST RECENT APPROVAL. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DAMAGE ON THE HEARTMATE POWER MODULE WAS CONFIRMED VIA EVALUATION OF THE RETURNED POWER MODULE. THE POWER MODULE WAS VISUALLY INSPECTED AT THE SERVICE DEPOT, WHERE DAMAGE TO THE STREAMLINE BATTERY CLIP WAS OBSERVED. WITHOUT REPLACING THE STREAMLINE BATTERY CLIP, THE POWER MODULE WAS CONNECTED TO A MOCK CIRCULATORY LOOP WITH A TEST 12V POWER MODULE BATTERY AND FUNCTIONED AS INTENDED FOR SEVERAL DAYS. THE POWER MODULE WAS RETURNED TO THE PRODUCT PERFORMANCE ENGINEERING (PPE) DEPARTMENT FOR FURTHER EVALUATION. THE DAMAGE TO THE STREAMLINE BATTERY CLIP WAS CONFIRMED UPON ARRIVAL. THE POWER MODULE WAS CONNECTED TO AC POWER AND BOOTED UP AS INTENDED. THE POWER MODULE WAS ABLE TO SUPPORT A MOCK CIRCULATORY LOOP WITH NO ATYPICAL ALARMS OR ISSUES PRODUCED. PROVIDED INFORMATION INDICATED THE POWER MODULE WAS DAMAGED UPON RECEIPT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE DETAILS OF THE DAMAGE, IMPACT TO DEVICE FUNCTION, AND ASSOCIATED ALARMS; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED. A ROOT CAUSE FOR THE REPORTED EVENT WAS NOT CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. A MANUFACTURING ANALYSIS HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE. INCIDENTAL FINDINGS: OUT-OF-BOX DEPLETED POWER MODULE BATTERY. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALS THAT THE HEARTMATE POWER MODULE, SERIAL NUMBER (B)(6), WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS. THE POWER MODULE WAS SHIPPED TO THE CUSTOMER ON 10MAY2024. THE HEARTMATE 3 INSTRUCTION FOR USE (IFU) AND HEARTMATE POWER MODULE INSTRUCTIONS FOR USE WERE AVAILABLE AT THE TIME OF THE EVENT. HEARTMATE 3 INSTRUCTION FOR USE, SECTION 3, ENTITLED ¿POWERING THE SYSTEM¿, AND HEARTMATE POWER MODULE INSTRUCTIONS FOR USE, SECTION 2, ENTITLED ¿SETTING UP THE POWER MODULE (PM) PRIOR TO USE¿, PROVIDE INSTRUCTIONS ON HOW TO INSTALL THE POWER MODULE BACKUP BATTERY AND GENERAL USE OF THE POWER MODULE. THE HEARTMATE 3 INSTRUCTIONS FOR USE, SECTION 8, ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ EXPLAINS HOW TO CARE FOR AND CLEAN THE POWER MODULE. THE HEARTMATE 3 PATIENT HANDBOOK 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 A BRAND-NEW POWER MODULE THAT ARRIVED DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703696 HEARTMATE® POWER MODULE (N/A) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 1340 10336544 00813024010654

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown