BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE®, MOBILE POWER UNIT, N/A

    MDR report key: 21067943 · Received January 3, 2025

    Report

    Report Number
    2916596-2024-52693
    Event Type
    Injury
    Date Received
    January 3, 2025
    Date of Event
    December 11, 2024
    Report Date
    March 19, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    05415067038234
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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

    SECTION E3: OCCUPATION CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF STATIC SHOCKS FROM THEIR MOBILE POWER UNIT (MPU) CABLE WAS UNABLE TO BE CONFIRMED. THE HEARTMATE MPU (SERIAL NUMBER: (B)(6) WAS NOT RETURNED FOR ANALYSIS; HOWEVER, LOG FILES WERE SENT FOR REVIEW. A REVIEW OF THE SUBMITTED AND DOWNLOADED LOG FILES CONTAINED OVERLAPPING DATA FROM THE REPORTED EVENT DATE (11DEC2024 PER TIMESTAMP). THERE WERE NO OTHER NOTABLE ALARMS OR EVENTS ACTIVE IN THE LOG FILE THAT WOULD INDICATE AN ISSUE WITH THE MPU. THE PUMP OPERATED AS INTENDED FOR THE DURATION OF THE LOG FILE. ADDITIONAL INFORMATION PROVIDED STATED THAT THE PATIENT WAS EDUCATED ON BEING ENVIRONMENTALLY CONSCIOUS OF STATIC ELECTRICITY AND THE SITUATION WOULD BE MONITORED. THE ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE MOBILE POWER UNIT (SERIAL NUMBER: (B)(6) AND FOUND TO HAVE PASSED ALL MANUFACTURING AND QA SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8 ¿ ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6 ¿ ¿CARING FOR EQUIPMENT¿ EXPLAIN HOW TO PROPERLY CARE FOR THE EQUIPMENT. ADDITIONALLY, HEARTMATE 3 PATIENT HANDBOOK SECTION 10 ENTITLED ¿SAFETY CHECKLISTS¿, INSTRUCTS USERS TO REGULARLY INSPECT THEIR ACCESSORIES FOR DAMAGE, AND TO REPLACE ANY EQUIPMENT THAT APPEARS DAMAGED OR WORN. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 3 ¿ ¿POWERING THE SYSTEM¿ EXPLAINS TO AVOID THE RISK OF ELECTRIC SHOCK, PLUG THE MOBILE POWER UNIT INTO A PROPERLY TESTED AC ELECTRICAL OUTLET THAT IS DEDICATED TO MOBILE POWER UNIT USE. DO NOT USE PORTABLE, MULTIPLE OUTLET (POWER STRIP) ADAPTERS OR EXTENSION CORDS. THE 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. 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 HAD DRIVELINE COMMUNICATION FAULT (B)(6) 2024 CAUSING THEM TO CHANGE TO THEIR BACKUP SYSTEM CONTROLLER ((B)(6)). THE EVENT LOG FILES CONFIRMED THE REPORTED DRIVELINE COMMUNICATION FAULT ON (B)(6) 2024 AT 02:13. THE DRIVELINE WAS DISCONNECTED AT 02:19. THE ALARM DID NOT RECUR AFTER SYSTEM CONTROLLER ((B)(6)) WAS EXCHANGED. THE EVENT LOG FILES ON (B)(6) 2024 REPORTED THAT THE DRIVELINE COMMUNICATION FAULT HAD RESOLVED. THE MODULAR CABLE (9213778) HAD NO BREAKS IN THE COVERING/COATING, BUT DID HAVE A KINK ABOUT HALFWAY DOWN AND WAS EXCHANGED WITH THE SYSTEM CONTROLLER ((B)(6)). A NEW BACKUP SYSTEM CONTROLLER ((B)(6)) WAS ISSUED. THE PATIENT ALSO REPORTED THAT THEY GET SMALL STATIC SHOCKS FROM THEIR CABLE ON THE MOBILE POWER UNIT. THE PATIENT WAS EDUCATED ON BEING ENVIRONMENTALLY CONSCIOUS OF STATIC ELECTRICITY, HUMIDITY, DRYER SHEETS, AND COTTON SHEETS. ALL OF THE EQUIPMENT WAS ISSUED THE DATE OF IMPLANT AND HAD BEEN WORKING AS INTENDED UNTIL (B)(6) 2024. OTHERWISE, THERE WERE NO OTHER NOTABLE ALARM CONDITIONS OR PARAMETER CHANGES, AND THE VENTRICULAR ASSIST DEVICE (VAD) WAS FUNCTIONING AS INTENDED. THE PATIENT REPORTED TO HAVE A DRIVELINE POWER FAULT ON (B)(6) 2024. THE PATIENT CHANGED TO THE BACKUP SYSTEM CONTROLLER ((B)(6)) AND THE ALARM REOCCURRED AFTER THREE HOURS. THE EVENT LOG FILES CAPTURED DRIVELINE POWER FAULT ALARMS BEGINNING AT 11:44 PM ON (B)(6) 2024 WHILE CONNECTED TO (B)(6). THE DRIVELINE WAS THEN DISCONNECTED AT 11:50 PM. FOLLOWING CONNECTION TO THE NEW SYSTEM CONTROLLER ((B)(6)) (TIME SET AT 12:21 AM), THE LOG FILES CONTINUED TO CAPTURE DRIVELINE POWER FAULT ALARMS BEGINNING AT 3:14 AM ON (B)(6) 2024 WHILE CONNECTED TO THE NEW SYSTEM CONTROLLER ((B)(6)). THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THE EQUIPMENT WAS OPERATING AS INTENDED. PICTURES OF THE DRIVELINE/MODULAR CABLE CONNECTION FROM (B)(6) 2024 CONFIRMED OXIDATION MIGHT HAVE BEEN CAUSING THE DRIVELINE FAULT ALARMS. A MODULAR CONNECTOR CLEANING WAS REQUESTED TO BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571965 HEARTMATE®, MOBILE POWER UNIT, N/A VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 107754 10105839 05415067038234

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Other