BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECMO-HEATER

    MDR report key: 2542973 · Received April 4, 2012

    Report

    Report Number
    1516825-2012-00001
    Event Type
    Malfunction
    Date Received
    April 4, 2012
    Date of Event
    January 11, 2012
    Report Date
    March 5, 2012
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT/UFR DATA INDICATES THAT THE CSZ DEVICE WORKED AS INTENDED AND THERE WAS NO PROBLEM WITH THE DEVICE FUNCTIONALITY. CSZ HAS NOT RECEIVED ANY SUCH COMPLAINT SINCE RELEASE OF ECMO HEATER IN 1986. VISUAL INSPECTION OF THE PHOTOGRAPHS AND INFORMATION PROVIDED BY THE USER INDICATE THAT THE DEVICE HAS BEEN PLACED TOO CLOSE TO THE EDGE OF THE SUPPORT OF THE ECMO CART WITH THE POWER SWITCH FACING THE SUPPORT. THE DEVICE HAS NOT BEEN SECURED TO THE BASE WITH THE TWO KNURL SCREWS (PROVIDED WITH THE DEVICE) AS DESCRIBED IN THE OPERATIONS MANUAL. CSZ IS FURTHER INVESTIGATING THE ISSUE WITH A REQUEST OF ADDITIONAL INFORMATION FROM THE USER. IN THE MEANTIME CSZ HAS RECOMMENDED USER TO FIXED MOUNT THE DEVICE TO THE CART WITH KNURL SCREWS (PROVIDED WITH THE CART) AS RECOMMENDED IN THE OPERATIONS MANUAL SUPPLIED WITH THE DEVICE. CSZ BELIEVES IT IS AN ECMO INSTALLATION ISSUE ON THE CART. CSZ IS WORKING WITH THE USER TO SOLVE THE ISSUE WHILE MAINTAINING PT AND USER SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT DURING 4 HOUR ROUTINE CHECK ON ECMO PT, IT WAS NOTED THE WATER BATH WAS OFF. WATER HEATER FOUND TO BE UP AGAINST SIDE OF CART, AND SWITCH ACCIDENTALLY TURNED OFF. PT TEMPERATURE WAS 34.6. H.R. APPROXIMATELY 119. WATER HEATER TURNED BACK ON. (B)(6) INCREASED TO BASELINE, APPROXIMATELY 127. ROLL OF TAPE PLACED BETWEEN HEATER AND SIDE OF CART AND TAPED IN PLACE TO PREVENT IT FROM HAPPENING AGAIN TILL PROTECTIVE COVER PLACED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECMO-HEATER THERMAL REGULATING SYSTEM DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 333W

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other