BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3040298 · Received April 3, 2013

    Report

    Report Number
    1828100-2013-00312
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 14, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE SUBSIDIARY ASSOCIATE, THE PRODUCT MIGHT BE REPAIRED AT THE MANUFACTURING ENGINEERING CENTER (MEC) SITE. WE ARE GOING TO ORDER PART FOR THE PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE LIQUID CRYSTAL DISPLAY (LCD) ON THE ROLLER PUMP WAS TURNED OFF. THE USER SAID THE PUMP COULD NOT BE CONTROLLED BY CENTRAL CONTROL MONITOR (CCM) THE FIRST TIME. THE USER PULLED OUT AND RECONNECTED THE POWER LINE, AND WERE ABLE TO CONTROL THE PUMP BY THE CCM AFTER THAT. THE LCD STILL DID NOT WORK. THE ROLLER PUMP WAS BEING USED AS A CARDIOPLEGIA PUMP. THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136624 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801041

    Patients

    Seq Age Sex Outcome Treatment
    1