BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL CIRCUIT, DUAL HTD LIMB, 60 IN

    MDR report key: 2771652 · Received September 26, 2012

    Report

    Report Number
    3004365956-2012-00293
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 18, 2012
    Manufacturer
    TELEFLEX
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNK. THE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS FOUND THAT THE EXPIRATORY LIMB HAD A 1-INCH MELT, 25-INCHES FROM THE PT WYE. THE INSPIRATORY LIMB HAD NO NOTICEABLE DEFECTS. THE TUBING APPEARS TO HAVE BEEN FLATTENED AT THE LOCATION OF THE MELT. THIS INDICATES IT MAY HAVE BEEN PINCHED OR BECAME WEDGED BETWEEN TWO OBJECTS. THE RESISTANCE OF THE INSPIRATORY AND EXPIRATORY WIRES WERE MEASURED AND BOTH WERE FOUND TO BE WITHIN ALLOWABLE RANGE. BASED ON THE INVESTIGATION PERFORMED, THE COMPLAINT OF MELTED CIRCUIT WAS CONFIRMED, HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE CAUSE OF A MELTED CIRCUIT INCLUDE NO FLOW, LOW FLOW, PROBE OUT, COVERED CIRCUITS, OR KINKED CIRCUITS. THE PRODUCT INSTRUCTIONS FOR USE(IFU) ALSO STATES SEVERAL WARNINGS IN ORDER TO AVOID OVERHEATING THE CIRCUIT. NO CONCLUSION CODE COULD BE CHOSEN AS THE COMPLAINT IS CONFIRMED, HOWEVER, A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES THAT THE CIRCUIT MELTED ON EXHALATION SIDE ONLY. PT AIRWAY TEMPERATURE SAID TO BE AT 37 DEGREES WITH NORMAL CONDENSATION. THE MELTED SPOT IS LOCATED IN ONLY ONE LOCATION ON EXPIRATORY CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL CIRCUIT, DUAL HTD LIMB, 60 IN NEONATAL HEATED WIRE CIRCUIT BZO TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1