BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC CENTRIMAG MOTOR

    MDR report key: 4886038 · Received July 1, 2015

    Report

    Report Number
    2916596-2015-01200
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 3, 2015
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WEIGHT WAS REQUESTED BUT WAS NOT PROVIDED. THE PRIMARY CONSOLE IS NOT A SINGLE USE DEVICE. THE APPROXIMATE AGE OF THE DEVICE FROM THE DATE OF MANUFACTURE IS 11 MONTHS. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT WAS CONFIRMED. THE RETURNED PRIMARY CONSOLE DID NOT DETECT THE RETURNED MOTOR AND ALARMED FOR MOTOR DISCONNECTED ALTHOUGH THE MOTOR WAS PROPERLY CONNECTED TO THE UNIT. HOWEVER, THE RETURNED PRIMARY CONSOLE OPERATED AS INTENDED WITH AN IN-HOUSE MOTOR. FURTHER ANALYSIS REVEALED THAT THE RETURNED MOTOR WAS DEFECTIVE. THE ROOT CAUSE FOR THE RETURNED MOTOR¿S DEFECT WAS FOUND TO BE A LOOSE SOLDERING CONNECTION INSIDE THE LEMO-CONNECTOR. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICES MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS SUPPORTED WITH AN EXTRACORPOREAL CIRCULATORY SUPPORT PUMP. IT WAS REPORTED THAT THE PRIMARY CONSOLE AND MOTOR WERE BOTH EXCHANGED DUE TO ¿THE DEVICE STOPPING¿ WHILE SUPPORTING THE PATIENT. IT WAS NOTED THAT THE SPECIFIC ALARMS OCCURRING AT THE TIME OF THE EVENT WERE UNKNOWN. THE ICU PERSONNEL REPORTED THAT THE TEMPERATURE SENSOR FOR THE OXYGENATOR ALARMED ¿LOW TEMPERATURE.¿ AT THAT TIME, IT WAS NOTED THAT THE BLOOD COMING FROM THE OXYGENATOR WAS DARKER THAN USUAL AND THE PRIMARY CONSOLE WAS READING LOWER FLOWS (APPROXIMATELY 1 LPM). AT THE TIME OF THE EVENT, THE PATIENT¿S OXYGENATION STATUS DECREASED SLIGHTLY, BUT SHE RECOVERED VERY QUICKLY AFTER THE EXCHANGE AND HAD NO LINGERING EFFECTS. THE PATIENT REMAINED ONGOING ON THE NEW PRIMARY CONSOLE AND MOTOR. THE PRIMARY CONSOLE AND MOTOR WERE QUARANTINED AND INSPECTED BY THE HOSPITAL¿S CLINICAL ENGINEERING DEPARTMENT AND NO OBVIOUS CAUSE FOR THE EVENT WAS NOTED. IT WAS MENTIONED THAT WHEN ATTEMPTING TO VIEW THE PRIMARY CONSOLE HISTORY, THE HISTORY ONLY SHOWED ALARMS RELATED TO CLINICAL ENGINEERING¿S TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425411 THORATEC CENTRIMAG MOTOR CENTRIMAG MOTOR DWA THORATEC SWITZERLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR