BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3896036 · Received May 15, 2014

    Report

    Report Number
    1828100-2014-00359
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 23, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. SOFTWARE DATA LOGS WERE RETURNED TO THE MANUFACTURER ON 04/23/2014 FOR FURTHER EVALUATION. PER THE SUBSIDIARY'S MANUFACTURING ENGINEERING CENTER (MEC), BY INSERTING AND REMOVING THE PUMP CABLE SEVERAL TIMES, THE LCD DISPLAYED OCCASIONALLY. THE UNIT WAS CHANGED OUT AND DUPLICATION CHECKS WERE CONDUCTED, BUT THE COMPLAINT ISSUE WAS NOT DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THERE WAS NO DISPLAY ON THE LIQUID CRYSTAL DISPLAY (LCD) OF THE LARGE ROLLER PUMP. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290368 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (ROLLER PUMP) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801041

    Patients

    Seq Age Sex Outcome Treatment
    1