BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 14 VOLT LITHIUM ION BATTERY SET

    MDR report key: 18777599 · Received February 26, 2024

    Report

    Report Number
    2916596-2024-00764
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    November 2, 2023
    Report Date
    February 26, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: INCIDENTAL FINDINGS: CORROSION 14V BATTERY ((B)(6) WAS RECEIVED WITH 14V BATTERY (B)(6) REGARDING A CHARGING ISSUE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE PRODUCT RETURN FOR 14V BATTERY ((B)(6); HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. AN EVALUATION WAS PERFORMED. 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. THE 14V BATTERY FUNCTIONED AS INTENDED. 14V BATTERY (B)(6) WAS MANUFACTURED ON 22MAY2023 BY THE SUPPLIER. THE BATTERY WAS RECEIVED FOR INSPECTION UNDER BATCH NUMBER 9082764. CARE AND MAINTENANCE OF THE HEARTMATE UNIVERSAL BATTERY CHARGER (UBC) ARE ADDRESSED IN THE HEARTMATE II INSTRUCTIONS FOR USE (REV C) AND THE HEARTMATE 3 INSTRUCTIONS FOR USE (REV C). 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¿. TO CONFIRM A BATTERY FAULT: 1. REMOVE THE BATTERY. EXAMINE THE BATTERY'S METAL CONTACT AND THE CONTACT INSIDE THE CHARGING POCKET. IF THERE IS NO DIRT, DEBRIS, OR OBSTRUCTION, CONTINUE TO STEP 2. 2. REINSERT THE BATTERY INTO THE SAME POCKET. 3. IF THE RED LIGHT COMES ON AGAIN, INSERT THE BATTERY INTO A DIFFERENT POCKET. 4. IF THE RED LIGHT COMES ON IN A SECOND POCKET, THE BATTERY IS DEFECTIVE. DO NOT USE IT. 5. OBTAIN THE ALARM CODE FOR THE BATTERY, IF POSSIBLE: A. PRESS AND HOLD THE NUMBER BUTTON FOR THIS POCKET. THE ALARM CODE APPEARS ON THE SCREEN. THE ALARM CODE IS ONE LETTER FOLLOWED BY FOUR NUMBERS. ALARM CODES RELATED TO BATTERIES BEGIN WITH THE LETTER "B." B. RECORD THE ALARM CODE AND SAVE IT FOR FUTURE REFERENCE. 6. REMOVE THE DEFECTIVE BATTERY FROM USE. TABLE 7.20 BATTERY CHARGER DISPLAY PANEL MESSAGES DESCRIBES THE MESSAGES THAT APPEAR ON THE CHARGER DISPLAY PANEL. 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 BATTERY WAS EXCHANGED. THE REASON FOR THE EXCHANGE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323481 HEARTMATE 14 VOLT LITHIUM ION BATTERY SET VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 2465 SX142-B005 00813024010692

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male