BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3807670 · Received March 19, 2014

    Report

    Report Number
    1828100-2014-00172
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 24, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) CONFIRMED THIS COMPLAINT. THE FSR REPLACED THE CARDIOPLEGIA (CPG) TEMP/PRESS PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) TO CORRECT THE PRESSURE DISPLAY GOING BLANK. THE FSR CHECKED THE CPG MONITOR CALIBRATIONS AND OPERATION, ALONG WITH THE SYSTEM OPERATION. THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT TEMP/PRESS PCBA WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE CARDIOPLEGIA (GPG) PRESSURE DISPLAY WENT BLANK WHEN THE CALIBRATION BUTTON WAS PRESSED. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163965 TERUMO PERFUSION SYSTEM 8000 8K DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16414

    Patients

    Seq Age Sex Outcome Treatment
    1