BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE®, 14V LI-ION RECHARGEABLE BATTERY SET

    MDR report key: 21267005 · Received January 29, 2025

    Report

    Report Number
    2916596-2025-00392
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    January 10, 2025
    Report Date
    May 27, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010692
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND 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 COMPLETE.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTIONS E2 AND E3 OCCUPATION CORRECTED. SECTION H5 CORRECTED TO "NO". SECTION H8 CORRECTED TO "REUSE". MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE CORROSION DAMAGE WAS CONFIRMED WITH RETURNED 14V BATTERY (SERIAL # (B)(6)). VISUAL INSPECTION REVEALED THE METAL CONTACT HAVE CORROSION DAMAGE. THE BATTERY PACK WAS ACCEPTED FOR CHARGE WITH NO ERROR CODE WHEN INSERTED INTO THE TEST UNIVERSAL BATTERY CHARGER. THE BATTERY PASSED THE DISCHARGE/CHARGE TEST USING AN ELECTRONIC LOAD BASED BATTERY TEST SYSTEM. THE CORROSION DAMAGE ON THE METAL CONTACT DID NOT RESULT IN ANY FUNCTIONAL ISSUE DURING THE EVALUATION. A ROOT CAUSE THAT LED TO THE CORROSION DAMAGE COULD NOT BE DETERMINED. 14V BATTERY (SERIAL # (B)(6)) WAS MANUFACTURED ON 18AUG2023 BY THE SUPPLIER. THE BATTERY WAS RECEIVED FOR INSPECTION UNDER BATCH NUMBER 9222063. HEARTMATE 3 INSTRUCTIONS FOR USE REV A. UNDER SECTION 3, BATTERY CHARGER OVERVIEW, DESCRIBES SETTING UP THE BATTERY CHARGER BEFORE USE ¿BEFORE USING THE BATTERY CHARGER TO CHARGE HEARTMATE BATTERIES, IT MUST BE PLUGGED IN AND TURNED ON. THE DISPLAY PANEL ON THE FRONT OF THE CHARGER DISPLAYS MESSAGES DURING SETUP AND OPERATION.¿ ALSO, UNDER ¿CHECKING BATTERY CHARGE STATUS USING THE ON-BATTERY POWER GAUGE¿, DESCRIBES HOW TO USE THE ON-BATTERY POWER GAUGE TO CONFIRM THAT THE BATTERY IS FULLY CHARGED. UNDER SECTION 7, ALARMS AND TROUBLESHOOTING, BATTERY RELATED ADVISORY MESSAGES ¿IF THE BATTERY CHARGER DETECTS A PROBLEM WITH A BATTERY, SUCH AS BATTERY VOLTAGE TOO HIGH OR TOO LOW, OR OPEN BATTERY CIRCUIT, THE RED LIGHT FOR THE POCKET COMES ON AND A TELEPHONE SYMBOL APPEARS ON THE DISPLAY PANEL TO INDICATE A BATTERY FAULT¿. UNDER SECTION D, SAFETY CHECKLISTS, REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S BATTERY TERMINALS WERE CORRODED AND SOME WERE PEELING OFF.

    Description of Event or Problem · 0

    TWO BATTERIES WOULD BE RETURNING. THE SERIAL NUMBERS WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590970 HEARTMATE®, 14V LI-ION RECHARGEABLE BATTERY SET VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 2465 SX230-B195 00813024010692

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female