BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECMO-HEATER

    MDR report key: 2137754 · Received June 18, 2011

    Report

    Report Number
    1516825-2011-00008
    Event Type
    Malfunction
    Date Received
    June 18, 2011
    Date of Event
    March 9, 2011
    Report Date
    May 19, 2011
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT (B)(4) WAS INITIATED AS A RESULT OF A USER FACILITY REPORT RECEIVED FROM FDA ON 05/19/2011. ACCORDING TO AN AMENDED USER FACILITY REPORT RECEIVED ON 06/16/2011, THE USER INQUIRED AS TO WHETHER MANUFACTURER'S INSTRUCTIONS FOR USE REQUIRE PLUGGING THE ECMO-HEATER INTO A RED OUTLET (A PROPERLY GROUNDED HOSPITAL GRADE RECEPTACLE). AS EVIDENT FROM THE UFR RECEIVED ON 05/19/2011 AND AN AMENDED UFR ON 06/16/2011, THE CINCINNATI SUB-ZERO ECMO-HEATER MODEL 333W WORKED AS INTENDED. THE OPERATION AND TECHNICAL MANUAL HAS DEVICE SPECIFICATIONS ON PAGE 11-12 (FIG 1-7). THE REQUIREMENT FOR PLUGGING THE ECMO-HEATER INTO A PROPERLY GROUNDED HOSPITAL GRADE RECEPTACLE IS LOCATED ON PAGE 15, SECTION 2-3.1(K). IT IS ALSO EVIDENT THAT THE BIOMED IS ALREADY AWARE THAT THE CINCINNATI SUB-ZERO ECMO-HEATER MODEL 333W PLUGS INTO A RED OUTLET, AND NOT INTO THE UNINTERRUPTED POWER SUPPLY OF THE ECMO. SINCE THE USER HAS ALREADY IDENTIFIED THE ROOT CAUSE OF THE COMPLAINT AND THE SOLUTION, AND THE CSZ ECMO-HEATER WORKED AS INTENDED, CSZ IS NOT TAKING ANY FURTHER ACTION. CSZ WILL HOWEVER, INFORM THE USER TO FOLLOW THE OPERATION AND TECHNICAL MANUAL WHICH INSTRUCTS THE USER TO PLUG THE ECMO-HEATER INTO A PROPERLY GROUNDED HOSPITAL GRADE RECEPTACLE.

    Description of Event or Problem · 1

    FROM USER FACILITY REPORT: PT ON ECMO PUMP. IT STOPPED FOR UNK REASON REQUIRING HAND CRANKING FOR ABOUT 3 MINS. STAFF NOTED THAT THE WATER HEATER ON PUMP WAS OFF ALSO. NO ALARMS INITIALLY, ALTHOUGH ALARMS WERE SET AND ON. PT'S HEART RATE DROPPED TO THE 50'S (NO INTERVENTION REQUIRED). PUMP WAS RESTARTED AND PT BACK ON ECMO. BIOMED WAS NOTIFIED AND AT BEDSIDE BIOMED DETERMINED ECMO-HEATER (CINCINNATI SUB-ZERO MODEL 333W) WAS CONNECTED TO THE UNINTERRUPTED POWER SUPPLY OF THE ECMO. THIS CAUSED THE UPS TO OVERLOAD AND TURN OFF. BIOMED TOLD THE USERS TO PLUG THE HEATER INTO RED OUTLET AND NOT INTO ECMO. NO FURTHER PROBLEMS WITH ECMO. CSZ REFERENCE NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECMO-HEATER CARDIOPULMONARY BYPASS TEMP. CONTROLLER DWC CINCINNATI SUB-ZERO PRODUCTS, INC. 333W

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR