BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4180567 · Received October 15, 2014

    Report

    Report Number
    1828100-2014-00859
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED. THE FIELD SERVICE REPRESENTATIVE (FSR) WAS UNABLE TO VERIFY THE BELT SLIP WHILE PERFORMING A FUNCTIONAL CHECK OF THE ROLLER PUMP. HE UPLOADED THE DATA LOGS TO BE EVALUATED. THE FSR REPLACED THE ROLLER PUMP WITH A LOANER ROLLER PUMP SERIAL NUMBER # (B)(4) AND PERFORMED A RELEASE TEST. THE UNIT OPERATED TO THE MFR'S SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT DEVICE WAS RETURNED TO THE MFR FOR FURTHER EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CARDIOPLEGIA PUMP CAME UP WITH A BELT SLIP ERROR CODE. THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, AND NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654573 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (ROLLER PUMP) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801041

    Patients

    Seq Age Sex Outcome Treatment
    1