BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1735940 · Received June 21, 2010

    Report

    Report Number
    9611451-2010-00385
    Event Type
    Other
    Date Received
    June 21, 2010
    Date of Event
    May 27, 2010
    Report Date
    May 27, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - METHOD: THE RETURNED RT134 BREATHING CIRCUIT WAS INSPECTED FOR MISSING COMPONENTS. RESULTS: THE WATER TRAP SPINDLE WAS MISSING FROM THE BREATHING CIRCUIT WATER TRAP, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 091218. CONCLUSION: THE RT132 BREATHING CIRCUIT FEATURES A WATER TRAP. THE WATER TRAP HAS A BOWL WHICH CAN BE REMOVED TO DRAIN CONDENSATE FROM THE BREATHING CIRCUIT AND A SPINDLE WHICH CLOSES OFF THE CIRCUIT WHEN THE WATER TRAP BOWL IS REMOVED. THE WATER TRAP SPINDLE WAS FOUND TO BE MISSING FROM THE COMPLAINT BREATHING CIRCUIT. EACH BREATHING CIRCUIT KIT CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. IT IS LIKELY THAT OPERATOR ERROR HAS RESULTED IN THE OMITTED WATER TRAP SPINDLE. THERE ARE STANDARD OPERATING PROCEDURES (SOPS) IN PLACE TO ASSIST OPERATORS ON THE PRODUCTION LINE CORRECTLY PACK BREATHING CIRCUITS. THIS CONSISTS OF A SPECIFIC PACK CARD DETAILING ALL COMPONENTS REQUIRED WHICH MUST BE DISPLAYED AT THE PACKING STATION. (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT THE WATER TRAP VALVE IS MISSING FROM AN RT134 ADULT BREATHING CIRCUIT KIT. THE MISSING COMPONENT WAS FOUND BY THE DISTRIBUTOR PRIOR TO DISTRIBUTION TO AN END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD. RT134 091218

    Patients

    Seq Age Sex Outcome Treatment
    1