BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 14 VOLT LITHIUM ION BATTERY SET

    MDR report key: 18582557 · Received January 25, 2024

    Report

    Report Number
    2916596-2024-00582
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Date of Event
    January 19, 2024
    Report Date
    April 9, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF CORROSION DAMAGE WAS CONFIRMED WITH THE RETURNED 14V BATTERY (SERIAL # (B)(6)). VISUAL INSPECTION OF THE RETURNED 14V BATTERY REVEALED THE METAL CONTACTS WERE CORRODED. OF NOTE, THE CORRODED DAMAGE DID NOT RESULT IN A SPECIFIC FUNCTIONAL ISSUE DURING TESTING. THE BATTERY WAS INSERTED INTO A TEST UNIVERSAL BATTERY CHARGER AND WAS ACCEPTED FOR CHARGE WITH NO ERROR CODE. THE BATTERY WAS CHARGE/DISCHARGE TESTED WITH AN ELECTRONIC LOAD BASED BATTERY TEST SYSTEM, WHICH MET DISCHARGE TIME REQUIREMENT. A ROOT CAUSE THAT LED TO THE CORRODED BATTERY CONTACTS COULD NOT BE DETERMINED THROUGH THIS ANALYSIS. 14V BATTERY (SERIAL # (B)(6)) WAS MANUFACTURED ON 10DEC2022 BY THE SUPPLIER. THE BATTERY WAS RECEIVED FOR INSPECTION UNDER BATCH NUMBER 8811132. HEARTMATE 3 PATIENT HANDBOOK REV G, CAUTIONS THE USERS TO ¿CALL YOUR HOSPITAL CONTACT IF YOU THINK THAT, FOR ANY REASON, ANY PORTION OF YOUR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR YOU ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. YOUR HOSPITAL CONTACT CAN CHECK THE EQUIPMENT AND ORDER REPLACEMENTS, IF NEEDED. DO NOT TRY TO REPAIR ANYTHING YOURSELF.¿ UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ DESCRIBES ALL ALARMS (VISUAL AND AUDIBLE) AND WHAT ACTION SHOULD BE PERFORMED WHEN THEY DO OCCUR. UNDER SECTION 3, POWERING THE SYSTEM, DESCRIBES HOW TO USE BOTH 14V BATTERY AND 14V BATTERY CLIPS. UNDER SECTION 8, ¿EQUIPMENT STORAGE AND CARE" DESCRIBE HOW TO CARE FOR AND CLEAN ALL EQUIPMENT. HEARTMATE 3 INSTRUCTIONS FOR USE REV G, 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.

    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 TWO BATTERIES WERE REPLACED DUE TO CORROSION. ADDITIONAL PRODUCT MFR# 2916596-2024-00581.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1974047 HEARTMATE 14 VOLT LITHIUM ION BATTERY SET VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 2465 GW344-B100 00813024010692

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male