BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMHEART ESCORT CONTROLLER

    MDR report key: 2994928 · Received February 8, 2013

    Report

    Report Number
    2531527-2013-00001
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    February 8, 2013
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    KFM
    PMA / PMN Number
    K991783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTROLLER WAS RECEIVED BY THE MANUFACTURER ON (B)(4) 2013 FOR ANALYSIS. THE PUMP IN THE REPORTED EVENT WAS ALSO REQUESTED FOR RETURN, BUT WAS DISCARDED BY THE FACILITY AND WAS NOT AVAILABLE FOR ANALYSIS. THE CONTROLLER DATA LOG WAS REVIEWED AND CONFIRMED REPORTS OF PUMP STOPS REQUIRING A MANUAL RESTART, AS WELL AS INDICATIONS OF THE CONTROLLER SWITCHING FROM PRIMARY TO SECONDARY MOTOR CONTROLLERS. AFTER CLEANING AND DECONTAMINATION, THE CONTROLLER WAS VISUALLY INSPECTED. NO SIGNS OF DAMAGE TO THE ENCLOSURE OR EXTERNAL CONNECTORS WERE NOTED. THE CONTROLLER WAS CONNECTED TO A KNOW GOOD PUMP AND ALLOWED TO OPERATE FOR 4 DAYS ON THE PRIMARY MOTOR CONTROLLER CIRCUIT. DURING THESE 4 DAYS, THE PUMP RAN CONTINUOUSLY AND NO SWITCH-OVER BETWEEN PRIMARY AND SECONDARY OCCURRED. THE CONTROLLER WAS THEN SWITCHED TO SECONDARY AND ALLOWED TO OPERATE THE PUMP FOR 2 DAYS. THE PUMP RAN CONTINUOUSLY ON A SECONDARY DURING THIS TIME. TO DATE, INVESTIGATION HAS BEEN UNABLE TO IDENTIFY A ROOT CAUSE OF THE INCIDENT REPORTED ON THE COMPLAINT. THE SUSPECT CONTROLLER OPERATED A KNOWN GOOD PUMP WITH NO ISSUES FOR 6 DAYS AND EFFORTS TO DATE TO REPRODUCE THE CONDITION ON THE CONTROLLER HAVE BEEN UNSUCCESSFUL. THE PUMP, WHICH ALSO COULD HAVE CONTRIBUTED TO THIS ISSUE, WAS NOT MADE AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, MS. (B)(6) OF THE CARDIAC ASSIST CLINICAL SUPPORT STAFF REPORTED CONCERNS ABOUT AN ESCORT CONTROLLER THAT HAD REPORTED CASES OF PUMP STOPPING, REQUIRING MANUAL RESTART BY THE OPERATOR. THE PUMP DID RESTART IN EVERY CASE, INCLUDING WHEN THE CONTROLLER WAS SWAPPED OUT TO ALLOW EVALUATION OF THE UNIT. NO PATIENT HARM HAS BEEN REPORTED. THIS CONTROLLER IS ALSO NEAR THE END OF ITS PM CYCLE, WITH SCHEDULED EVALUATION AND PM DUE THIS MONTH. AFTER CONTROLLER WAS CHANGED OUT, THE CASE PROCEEDED WITH NO FURTHER COMPILATIONS. TANDEM-HEART SYSTEM DISCONTINUED AND REMOVED ON (B)(6) 2013, WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55011 TANDEMHEART ESCORT CONTROLLER NON-ROLLER BEARING BYPASS PUMP CONTROLLER KFM CARDIAC ASSIST, INC. 5140-8500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MAQUET IABP