BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE II®, SYSTEM CONTROLLER

    MDR report key: 18886423 · Received March 12, 2024

    Report

    Report Number
    2916596-2024-01188
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    February 16, 2024
    Report Date
    June 13, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011286
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    A4 ¿ PATIENT WEIGHT: CORRECTED. D1 ¿ BRAND NAME: CORRECTED. D4 ¿ UDI: CORRECTED. D4 ¿ CATALOG NUMBER: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENTS OF THE BATTERIES BECOMING DEPLETED, RESULTING IN A NO EXTERNAL POWER ALARM, AND THE PATIENT¿S DRIVELINE BECOMING DISCONNECTED, WERE BOTH CONFIRMED VIA THE PROVIDED LOG FILE FROM THE PATIENT¿S PRIMARY CONTROLLER. THE LOG FILE CONTAINED DATA SPANNING APPROXIMATELY 44 DAYS ((B)(6)2024 ¿ (B)(6)2024 PER TIMESTAMP), AND THE PUMP OPERATED AT INTENDED SPEEDS WHILE CONNECTED TO THE DRIVELINE. THE PATIENT WAS OBSERVED TO HAVE CONNECTED TO BATTERIES WITH A LOW CHARGE ON (B)(6) 2024, AND A LOW VOLTAGE ADVISORY ALARM WAS ACTIVE AT THIS TIME. APPROXIMATELY 40 MINUTES LATER, THIS ALARM TRANSITIONED INTO A LOW VOLTAGE HAZARD DUE TO EXTENDED USE OF THE LOW-CHARGED BATTERIES. A NO EXTERNAL POWER ALARM BECAME ACTIVE ON (B)(6) 2024 ONCE BOTH BATTERIES HAD FULLY DEPLETED, AND THE BACKUP BATTERY OPERATED THE SYSTEM AT THIS TIME. APPROXIMATELY 2 MINUTES LATER, THE PATIENT¿S DRIVELINE WAS OBSERVED TO HAVE BEEN DISCONNECTED, STOPPING THE PUMP, WHILE THE NO EXTERNAL POWER ALARM WAS ACTIVE. THE DRIVELINE WAS RECONNECTED APPROXIMATELY 6 MINUTES AFTER ITS DISCONNECTION, AND THE PUMP RESUMED OPERATING AT INTENDED SPEEDS. THE LOW VOLTAGE/NO EXTERNAL POWER ALARMS RESOLVED WHEN THE PATIENT SWITCHED POWER SOURCES. THE SYSTEM CONTROLLER (SERIAL NUMBER (B)(6)) WAS NOT RETURNED FOR ANALYSIS. PER ADDITIONAL INFORMATION, THE PATIENT STATED THAT THE NO EXTERNAL POWER ALARM WAS CAUSED BY ALLOWING THE BATTERIES TO FULLY DEPLETE AND THAT THEY DISCONNECTED THEIR DRIVELINE FROM THE CONTROLLER IN RESPONSE TO THE ALARM. NO ADVERSE CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENTS, AND THE PATIENT WAS IN STABLE CONDITION. THE ROOT CAUSE OF THE SYSTEM STOP WAS DETERMINED TO BE THE PATIENT DISCONNECTING THE DRIVELINE FROM THE SYSTEM CONTROLLER IN A MANNER THAT WAS NOT RECOMMENDED PER THE LABELING. IT IS UNKNOWN IF THE PATIENT WAS IN A CONDITION TO RESPOND TO CONTROLLER ALARMS LEADING UP THE NO EXTERNAL POWER ALARM. THERE WERE NO DEVICE ISSUES IDENTIFIED DURING EVALUATION OF THE LOG FILES AND THE REPORTED EVENTS CANNOT BE CORRELATED TO A DEVICE RELATED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD FOR THE SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE CONTROLLER WAS SHIPPED TO THE CUSTOMER ON 01SEP2016. THE HEARTMATE II PATIENT HANDBOOK (REV. C, SECTION 2 ¿HOW YOUR HEART PUMP WORKS¿) INSTRUCTS USERS THAT BACKUP BATTERY POWER SHOULD ONLY BE USED WHEN IN A POWER LOSS EMERGENCY. INAPPROPRIATE USE OF THE BACKUP BATTERY¿S POWER MAY RESULT IN DIMINISHED RUN TIME DURING A POWER LOSS EMERGENCY. THIS SECTION ALSO INSTRUCTS USERS THAT TWO NEW FULLY CHARGED 14-VOLT BATTERIES ARE EXPECTED TO OPERATE THE SYSTEM FOR APPROXIMATELY 10-12 HOURS, DEPENDING ON YOUR ACTIVITY LEVEL. THIS SECTION ALSO INSTRUCTS USERS TO REGULARLY ENSURE THAT THEIR DRIVELINE IS CONNECTED AND SECURED WITHIN THE SYSTEM CONTROLLER, AND TO RECONNECT IT IMMEDIATELY IN THE CASE THAT IT BECOMES DISCONNECTED. USERS ARE WARNED THAT THE PUMP WILL STOP RUNNING WHEN THE DRIVELINE IS DISCONNECTED. THE HEARTMATE II PATIENT HANDBOOK (REV. C, SECTION 3 ¿POWERING THE SYSTEM¿) INSTRUCTS USERS ON HOW TO CHECK THE CHARGE OF THEIR BATTERIES VIA ITS FUEL GAUGE BUTTON. USERS ARE INSTRUCTED TO ALWAYS CHECK THE BATTERY¿S CHARGE BEFORE PUTTING IT INTO USE AND TO ALWAYS USE FULLY CHARGED BATTERIES. THE HEARTMATE II PATIENT HANDBOOK (REV. C, SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿) DESCRIBES ALL ALARMS (VISUAL AND AUDIBLE) AND WHAT ACTION SHOULD BE PERFORMED WHEN THEY DO OCCUR, INCLUDING THE LOW VOLTAGE AND NO EXTERNAL POWER ALARMS. USERS ARE INSTRUCTED TO RECONNECT THEIR POWER CABLES TO EITHER WALL POWER OR FULLY CHARGED BATTERIES TO RESOLVE THE ALARMS. THIS SECTION ALSO INSTRUCTS USERS ON HOW TO RESPOND TO AND RESOLVE DRIVELINE DISCONNECTED ALARMS. THE HEARTMATE II PATIENT HANDBOOK (REV. C, SECTION TITLED "EMERGENCY CONTACT LIST") CAUTIONS 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 THE PRIMARY SYSTEM CONTROLLER APPEARED TO HAVE BEEN WITHOUT POWER FOR 6 MINUTES ON (B)(6) 2024. THE PATIENT PRESENTED TO AN OUTSIDE HOSPITAL EMERGENCY ROOM AT 1830 ON (B)(6) 2024, AND THE SITE STATED THAT THE OUTSIDE HOSPITAL ATTEMPTED TO PERFORM A CONTROLLER EXCHANGE TO THE PATIENT'S BACKUP. LOG FILE REVIEW WAS REQUESTED AND CONTAINED ALARMS ASSOCIATED WITH A LOSS OF EXTERNAL POWER EVENT. THE PATIENT APPEARED TO HAVE BEEN UTILIZING BATTERY POWER ON (B)(6) 2024 AND DEPLETED BOTH BATTERIES. DURING THE EVENT, THE CONTROLLER DID SWITCH APPROPRIATELY TO THE BACKUP BATTERY (BB). WHILE IN BB MODE THE LOG FILE INDICATED THE DRIVELINE WAS BRIEFLY DISCONNECTED AND RECONNECTED CAUSING THE PUMP STOP EVENTS. THE EVENT ALARMS APPEARED TO RESOLVE ONCE EXTERNAL POWER WAS RECONNECTED. THE PUMP THEN RESUMED NORMAL OPERATION. TECHNICAL SERVICES NOTED THAT THE PATIENT DID NOT APPEAR TO HAVE BEEN SWAPPED OVER TO THE BACKUP CONTROLLER AS THAT FILE DID NOT SHOW ANY PUMP CONNECTION SINCE 2017. IT WAS ALSO NOTED THAT THE PATIENT APPEARED TO BE SLEEPING ON BATTERY POWER WHICH WAS NOT RECOMMENDED. ACCORDING TO THE PATIENT, THE NO EXTERNAL POWER (NEP) EVENT WAS DUE TO THEIR BATTERIES BEING DRAINED. IT WAS ALSO NOTED BY THE PATIENT THAT THE REASON FOR THE DRIVELINE BEING DISCONNECTED AND RECONNECTED WAS BECAUSE THEIR BATTERIES WERE DRAINED. THE SITE NOTED THAT THE CAUSE OF THE NEP EVENT AND THE DISCONNECTION OF THE DRIVELINE WERE ALL HEAR-SAY. THE PATIENT DID NOT HAVE ANY ADVERSE CONSEQUENCES/SYMPTOMS DURING THE PUMP STOP. THE SITE NOTED THAT THEY WERE OBSERVED AT THE HOSPITAL AND THE PATIENT WAS FINE. IT WAS UNKNOWN WHY THE CONTROLLER WAS BEING CHANGED. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2024-01151 (PUMP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385368 THORATEC® HEARTMATE II®, SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106762 00813024011286

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male