BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLANKETROL

    MDR report key: 6266025 · Received January 20, 2017

    Report

    Report Number
    6266025
    Event Type
    Malfunction
    Date Received
    January 20, 2017
    Date of Event
    December 7, 2016
    Report Date
    December 22, 2016
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, LLC
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH HYPOXIC ISCHEMIC ENCEPHALOPATHY VS. MECONIUM ASPIRATION SYNDROME ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) DAY 3. REPORTEDLY, RN NOTICED PATIENT TEMPERATURE DECREASING DURING 0440 LAB DRAW. RN INCREASED TEMPERATURE OF RADIANT HEAT SOURCE. AROUND THIS TIME THE INFANT BEGAN HEMORRHAGING FRANK RED BLOOD FROM ENDOTRACHEAL TUBE AND BECAME BRADYCARDIC. CODE INITIATED AT 0543. AT APPROXIMATELY 0600 THE PERFUSIONIST ARRIVED AT BEDSIDE AND NOTED WATER BATH NOT FUNCTIONING. RN ATTEMPTED TO TAKE PATIENT TEMPERATURE. TEMPERATURE WAS UNREADABLE. WATER BATH REMOVED FROM SERVICE. A NEW MACHINE WAS BROUGHT TO THE BEDSIDE. INVESTIGATION ONGOING. AFTER ADDITIONAL INVESTIGATION, IT WAS FOUND THAT A SAFETY MECHANISM SHUT THE WATER BATH OFF WHEN A SCHEDULED GENERATOR TEST WAS BEING PERFORMED THROUGHOUT THE HOSPITAL. REPORTEDLY, LIGHTS ON THE DEVICE REMAINED ON BUT THE WATER PUMP INDICATOR ON THE SIDE STOPPED ROTATING, MEANING WATER WAS NO LONGER BEING CIRCULATED. THERE WERE NO ALARMS THAT SIGNALED THAT THE DEVICE WAS BEING SHUT DOWN. THE SHUTDOWN OF THE DEVICE WENT UNNOTICED FOR APPROXIMATELY 1 HOUR WHICH CAUSED THE PATIENT¿S TEMPERATURE TO DECREASE AFTER WHICH THE ABOVE EVENTS OCCURRED.

    Description of Event or Problem · 1

    PATIENT WITH HYPOXIC ISCHEMIC ENCEPHALOPATHY VS. MECONIUM ASPIRATION SYNDROME ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) DAY 3. REPORTEDLY, RN NOTICED PATIENT TEMPERATURE DECREASING DURING 0440 LAB DRAW. RN INCREASED TEMPERATURE OF RADIANT HEAT SOURCE. AROUND THIS TIME THE INFANT BEGAN HEMORRHAGING FRANK RED BLOOD FROM ENDOTRACHEAL TUBE AND BECAME BRADYCARDIC. CODE INITIATED AT 0543. AT APPROXIMATELY 0600 THE PERFUSIONIST ARRIVED AT BEDSIDE AND NOTED WATER BATH NOT FUNCTIONING. RN ATTEMPTED TO TAKE PATIENT TEMPERATURE. TEMPERATURE WAS UNREADABLE. WATER BATH REMOVED FROM SERVICE. A NEW MACHINE WAS BROUGHT TO THE BEDSIDE. INVESTIGATION ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51800 BLANKETROL SYSTEM, THERMAL REGULATING DWJ CINCINNATI SUB-ZERO PRODUCTS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR