BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4168798 · Received October 8, 2014

    Report

    Report Number
    1828100-2014-00823
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THE FSR WILL RETURN TO REPLACE THE PC BOARD ON THE LARGE ROLLER PUMP. SOFTWARE DATA LOGS WERE RECEIVED BY THE MANUFACTURER ON (B)(4) 2014.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT HE ATTEMPTED TO PERFORM A NOTICE OF FIELD CORRECTION (NFC) OF THE ROLLER PUMP AND WAS UNSUCCESSFUL. THE ROLLER PUMP WOULD NOT POWER UP AND THE CODE ON THE SERVICE AND DIAGNOSTIC SCREEN WAS "OC." THE ROLLER PUMP WAS OUT OF CALIBRATION (OOC). THE ROLLER PUMP WAS A BACKUP PUMP AND WAS NOT LOCATED ON THE HEART LUNG CONSOLE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633713 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801041

    Patients

    Seq Age Sex Outcome Treatment
    1