BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 6165305 · Received December 11, 2016

    Report

    Report Number
    1828100-2016-00792
    Event Type
    Malfunction
    Date Received
    December 11, 2016
    Report Date
    August 10, 2017
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWB
    PMA / PMN Number
    K131618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED: INITIAL REPORTER. AS PER PERFUSIONIST, THE ISSUE HAPPENED 2-3 WEEKS BEFORE THE PREVENTIVE MAINTENANCE (PM). HE WAS UNSURE WHAT WAS DONE TO FIX THE ISSUE BUT CONFIRMED THAT THEY HAVEN'T HAD ANY ISSUES AFTER THE PM.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS NOT CONFIRMED. DURING PREVENTIVE MAINTENANCE (PM) IN JANUARY 2017, THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT NO ISSUES WERE FOUND AND UNIT MET THE MANUFACTURER'S SPECIFICATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE PERFUSIONIST NOTICED THAT THE SCREEN OF THE PUMP WAS "FUZZY" LOOKING AND WOULD TEMPORARILY LOSE DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815724 LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1 PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP FOR ADVANC DWB TERUMO CARDIOVASCULAR SYSTEMS CORP. 816571

    Patients

    Seq Age Sex Outcome Treatment
    1