BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HX2 TEMPERATURE MANAGEMENT SYSTEM

    MDR report key: 3862874 · Received February 20, 2014

    Report

    Report Number
    1828100-2014-00072
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 29, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K071521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TOOK THE HEATER COOLER UNIT TO ANOTHER ROOM TO SEE IF IT WOULD TRIP THE LIM IN THAT ROOM, AND IT DID. CUSTOMER WANTS TO MAKE THE REPAIRS HIMSELF. IN THIS CASE, THE ISSUE WAS CORRECTED BY THE REPLACEMENT OF THE HEATING ELEMENT. THE HEATING ELEMENT IS INCASED IN A METAL HOUSING, WHICH IS SECURED TO THE CHASSIS OF THE HX2 HEATER COOLER. THE CHASSIS OF THE HEATER COOLER IS ATTACHED TO EARTH GROUND THROUGH THE POWER CORD. IN THIS CASE, THE HEATER ELEMENT IS SHORTING TO GROUND AND IS NOT A SHOCK HAZARD. THE ELEMENT WOULD EVENTUALLY SHORT OUT AND TRIP THE 15AMP MAIN CIRCUIT BREAKER ON THE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE HEATER COOLER UNIT TRIPPED THE LINE ISOLATION MONITOR (LIM) ALARM. THERE WAS EXCESS CURRENT LEAKAGE WHEN RUNNING GOES OVER TWO MILLI AMPS. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. 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
    106595 HX2 TEMPERATURE MANAGEMENT SYSTEM HX2 TEMPERATURE MANAGEMENT SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 809810

    Patients

    Seq Age Sex Outcome Treatment
    1