BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II POCKET CONTROLLER

    MDR report key: 3979027 · Received July 10, 2014

    Report

    Report Number
    3979027
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 10, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON FRIDAY EVENING ABOUT 8:50PM AS PATIENT WAS TAKING A WALK, PATIENT HEARD AN ALARM ON HIS POCKET CONTROLLER. HE SAW A YELLOW WRENCH IN ADDITION THE DRIVELINE FAULT ALARM AND CONTACT HOSPITAL PERSONNEL WERE VISIBLE IN THE DISPLAY SCREEN. HE SILENCED THE ALARM AND CALLED THE LVH VAD EMERGENCY LINE. PA-C RESPONDED TO THE CALL. AFTER SPEAKING WITH THE PATIENT, SHE THEN CALLED THE PHYSICIAN AND THE THORATEC CLINICAL SUPPORT TO DISCUSS THE PLAN. THE PATIENT FELT WELL, ALL PUMP PARAMETERS WERE WITHIN HIS NORMAL RANGE. BUT SECONDARY TO THE SERIOUSNESS OF THE ALARM HE WAS BROUGHT INTO THE OFFICE FOR EVALUATION. AS THERE ARE FALSE POSITIVE DRIVELINE FAULT ALARMS, THE STANDARD PROCESS IS TO CONNECT TO THE SYSTEM MONITOR AND CLEAR THE ALARM. FOLLOWING THE THORATEC CORP. ALGORITHM WE CLEARED THE ALARMS BUT IT RETURNED APPROXIMATELY 10 MINUTES LATER; WE REPEATED THE ALARM CLEARING PROCEDURE 2 MORE TIMES. EACH TIME IT RETURNED WITHIN 5 TO 10 MINUTES. AGAIN ALL PUMP PARAMETERS REMAINED WITHIN IN HIS NORMAL RANGE. (SPEED 8980 TO 9000; FLOW 4.0 TO 4.9; PUMP POWER 4.9 TO 5.4; PULSE INDEX 7.2 TO 8.1) HE CONTINUED TO FEEL WELL. WE MANIPULATED THE DRIVELINE IN AN ATTEMPT TO REPRODUCE AN ALARM, THUS ATTEMPTING TO VALIDATE A TRUE DRIVELINE FRACTURE. WE COULD NOT REPRODUCE THE ALARM. THE NEXT STEP WAS TO REPLACE THE CONTROLLER. BEFORE PROCEEDING TO THE EXCHANGE, WAVEFORMS WERE DOWNLOADED AND SENT TO THORATEC CORP. THE PATIENT WAS PLACED IN A BED AND HIS BACKUP CONTROLLER WAS USED FOR THE EXCHANGE. THE CONTROLLER EXCHANGE WAS UNEVENTFUL. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS DURING THE EXCHANGE. HE WAS GIVEN A NEW CONTROLLER TO BE USED AS BACKUP. THE PATIENT CONNECTED HIS NEW BACKUP CONTROLLER TO BATTERIES IN ORDER TO CHARGE THE BACKUP BATTERY HOUSED WITHIN THE CONTROLLER. HE REMAINED WITH US FOR ABOUT 30 MINUTES AFTER THE EXCHANGE DURING WHICH TIME HE WALKED AROUND THE AREA, IN ADDITION THE DRIVELINE WAS MANIPULATED BUT THE ALARM NEVER RETURNED. PRIOR TO LEAVING THE FOLLOWING PUMP PARAMETERS WERE OBSERVED; SPEED 8990; FLOW 4.9; PUMP POWER 5.2; PULSE INDEX 7.9. HE WAS THEREFORE ALLOWED TO RETURN HOME. THE EQUIPMENT WAS RETURNED TO THORATEC CORP. AND A REPLACEMENT WAS PROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405311 HEARTMATE II POCKET CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORP. 106T62 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR