BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2981682 · Received February 27, 2013

    Report

    Report Number
    9611451-2013-00137
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    December 16, 2012
    Report Date
    January 29, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS NOT RETURNED TO FPH FOR INVESTIGATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE INCIDENT REPORT PROVIDED BY THE HOSPITAL AND OUR KNOWLEDGE OF THE PRODUCT. BASED ON THE REPORT PROVIDED BY THE HOSPITAL, THE SKIN BURN SUSTAINED BY THE PATIENT WAS DUE TO THE DRAPING PLACED ON TOP OF THE RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT WHEN THE PATIENT WAS PLACED ON THE ECMO MACHINE. THE HOSPITAL CONFIRMED IN THEIR INCIDENT REPORT THAT IT WAS A "PRODUCT USE ERROR". FPH OFFICE IN (B)(4) HAS CONTACTED THE HOSPITAL TO REMIND THEM OF THE FOLLOWING WARNINGS STATED IN THE USER INSTRUCTIONS OF THE RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT: - "AVOID PROLONGED CONTACT WITH PATIENT'S SKIN."- "DO NOT COVER THE CIRCUIT WITH MATERIALS SUCH AS BLANKETS, TOWELS OR BED LINEN."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) ADVISED FISHER & PAYKEL HEALTHCARE (FPH) OF THE FOLLOWING INCIDENT, REPORTEDLY INVOLVING AN RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT: "PATIENT ADMITTED FROM OUTLYING ED TO THE CARDIAC INTENSIVE CARE UNIT ON (B)(6) 2012 POST CARDIA ARREST AND INTUBATION. PATIENT ADMITTED WITH PROBABLE SEPTIC SHOCK AND SEVERE RIGHT VENTRICULAR FAILURE. PATIENT PREPPED AND DRAPED FOR PLACEMENT OF VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATOR (ECMO). PATIENT CANNULATED AND PLACED ON ECMO. POST DRAPING REMOVED AND NURSING NOTED A REDDENED AREA TO RIGHT LOWER ABDOMEN AND RIGHT UPPER THIGH CORRELATING TO WHERE THE VENTILATOR TUBING WAS IN CONTACT WITH THE PATIENT'S SKIN. PATIENT EVALUATED AND TREATED BY WOUND CARE TEAM. BOTH BURNS NOTED TO BE PARTIAL THICKNESS BURNS WITH THE RIGHT UPPER THIGH NOTED TO HAVE BLISTERED. WOUND CARE TEAM DISCONTINUED CARE FOR THE ABDOMINAL BURN ON (B)(6) 2013 AS THE BURN HAD HEALED. PATIENT STILL UNDER CARE AT TIME OF DISCHARGE FOR BURN TO RIGHT UPPER THIGH AS BLISTER HAD OPENED AND WOUND WAS BEING CLEANED AND DRESSED. CARE OF THE PATIENT WAS TRANSFERRED TO A FACILITY CLOSER TO PATIENT'S HOME ON (B)(6) 2013." THE HOSPITAL REPORTED THIS INCIDENT TO THE FDA ON (B)(6) 2013 AS "PRODUCT USE ERROR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83592 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT235 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATOR| FPH MR290 AUTOFEED HUMIDIFICATION CHAMBER