BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3813226 · Received March 26, 2014

    Report

    Report Number
    1828100-2014-00190
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 3, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SYSTEM WAS FOUND IN PUMP ROOM IN THE MORNING DURING SET-UP. THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) TESTED THE UNIT AND FOUND THE A/C LINE LOOSE IN THE PLUG. THIS SITE HAS REMOVED THE MANUFACTURER'S PLUG AND APPLIED A 20AMP HUBLE PLUG TO ACCOMMODATE WHAT THE SITE HAS IN O/R. THE BIOMED TIGHTENED THE CONNECTION, TESTED THE UNIT AND IT IS NOW WORKING CORRECTLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) STATED THE PERFUSION SYSTEM BASE WAS NOT TAKING A CHARGE. THE CUSTOMER DID NOT USE THIS SYSTEM FOR ANY CASES. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. 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
    176865 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1