BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3896740 · Received May 19, 2014

    Report

    Report Number
    1828100-2014-00417
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 25, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED. THIS COMPLAINT IS RELATED TO THE FOLLOWING MDR #'S: 1828100-2014-00428, -00427, -00426, -00424, -00423, -00422, -00421, -00420, -00419, -00418 AND -00416. THE FIELD SERVICE REP (FSR) REPLACED THE PUMP LIDS, TESTED THE PUMP OPERATION PERTAINING TO THE OCCLUSION AND PUMP LID OPERATION AND CONTROL OF THE ROLLER PUMP. THE SYSTEM OPERATED TO MFR SPECS AND WAS RETURNED TO CLINICAL USE. THE FSR DOWNLOADED THE DATE LOGS AND RETURNED THE SUSPECT LIDS TO THE MFR FOR FURTHER EVAL.

    Description of Event or Problem · 1

    THE PERFUSIONIST (CCP) CALLED THE FIELD SERVICE REP (FSR) AND REPORTED THE PUMP LID WAS FALLING OFF THE ROLLER PUMP ON THE PERFUSION SYSTEM. THE DEVICE WAS NOT CHANGED OUT. THERE IS NO SPECIFIC DATE, TIME OR OCCURRENCES OF THE ISSUE WHICH CAN HAPPEN AT ANY TIME THE SYSTEM IS USED. THIS COMPLAINT HAS NO REPORTS OF ANY DELAY, OR IMPACT TO A CASE DUE TO THIS ISSUE. NO HARM HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296113 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (ROLLER PUMP) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816571

    Patients

    Seq Age Sex Outcome Treatment
    1