BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLANKETROL III

    MDR report key: 1942950 · Received December 20, 2010

    Report

    Report Number
    1516825-2010-00017
    Event Type
    Other
    Date Received
    December 20, 2010
    Report Date
    October 18, 2010
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    PMA / PMN Number
    K101589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER SPEAKING WITH THE NURSE (B)(6), IT WAS AGREED UPON THAT IT WAS A USER ERROR AND THE STAFF WAS NOT AWARE OF HOSE CONNECTION PROTOCOL/VERIFICATION PROVIDED IN THE OPERATORS MANUAL (SECTION 2-3.1 G PAGE 18) "TO ATTACH THE COUPLINGS". THE NURSE WAS INFORMED OF HOSE/COUPLING ATTACHMENT INSTRUCTIONS PROVIDED IN THE OPERATORS MANUAL SUPPLIED WITH THE BLANKETROL III SYSTEM. THE NURSE'S CONCERN WAS THAT THIS PROCEDURE HAPPEN VERY INFREQUENTLY (4-5 TIMES A YEAR), AND GENERALLY AT NIGHT WITH NIGHT SHIFT STAFF. WE HAVE ALSO OFFERED IN-SERVICE TRAINING IF SO REQUESTED FOR ANYONE INCLUDING NIGHT SHIFT STAFF. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE PATIENT WAS PLACED ON TOTAL BODY COOLING THAT NEEDS TO BE INITIATED BEFORE 6 HOURS OF AGE. APPROXIMATELY 5 HOURS AFTER THE PROTOCOL WAS INITIATED, THE "SAIL" WAS CHANGED BECAUSE IT WAS LEAKING. THEN, 5 HOURS LATER, BIOMEDICAL ENGINEERING WAS CALLED BECAUSE "SOMETHING JUST WASN'T RIGHT". BIOMED NOTICED THAT THE SAIL WAS WET AND THE HOSES AND MACHINE WERE EXTREMELY COLD. THE BLANKET TEMPERATURE REMAINED AROUND 5 DEGREES DESPITE THE PATIENT NOT REACHING THE DESIRED TEMPERATURE. UPON EXAMINING, THE COLLAR AROUND THE HOSE WAS NOTED TO SNAP IN PLACE WHEN THEY WERE MANIPULATED. IMMEDIATELY, THE MACHINE CYCLED MORE WATER THROUGH THE PATIENT COOLING BLANKET AND THE PATIENT'S TEMPERATURE, WITHIN 20 MINUTES OR SO, REACHED THE DESIRED TEMPERATURE. AT THIS POINT, THE BLANKET TEMPERATURE STARTED TO ADJUST IN ACCORDANCE WITH THE PATIENT'S TEMPERATURE. APPARENTLY, THE HOSES TO THE PATIENT BLANKET WERE NOT FULLY ENGAGED, LIMITING CIRCULATING WATER TO THE PATIENT BLANKET. THIS RESULTED IN THE INFANT LYING ON A BLANKET FOR MANY HOURS THAT WAS BETWEEN 5-10 DEGREES C. THIS ALSO RESULTED IN THE PATIENT NOT RECEIVING OPTIMAL TEMPERATURE FOR AT LEAST 8 HOURS WHEN GENERALLY, THIS IS REACHED IN 2 HOURS. OTHER THAN HEARING THE COLLAR CLICK OVER THE CONNECTION, AND VISUALLY INSPECTING, THERE IS NO CLEAR INDICATOR. IF THE HOSES ARE PULLED ON, THEY APPEAR FULLY ENGAGED. THIS EVENT DID NOT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE. THE INTENDED PROCEDURE WAS TO PROVIDE TOTAL BODY COOLING TO NEWBORN EXPERIENCING NEUROLOGICAL COMPLICATIONS. THE PATIENT WAS A NEWBORN (B)(6) MALE WEIGHING (B)(6). THERE WAS NO APPARENT INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLANKETROL III THERMAL REGULATING SYSTEM DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 233

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other