BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE CPAP SYSTEM

    MDR report key: 2800778 · Received October 22, 2012

    Report

    Report Number
    9611451-2012-00746
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 5, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K100011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE TWO COMPLAINT BUBBLE CPAP KITS, ONE FROM LOT 120806 AND ONE FROM LOT 120808, WERE RECEIVED IN UNSEALED BAGS AND WERE VISUALLY INSPECTED. RESULTS: THE KIT FROM LOT 120806 WAS MISSING THE WHITE EXPIRATORY LIMB FROM THE BREATHING CIRCUIT. THE KIT FROM LOT 120808 WAS MISSING THE BLUE INSPIRATORY EXTENSION FROM THE BREATHING CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR EITHER LOT NUMBER PROVIDED. CONCLUSION: THE BUBBLE CPAP CIRCUIT KIT CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. IT IS LIKELY THAT OPERATOR ERROR, DURING THE PACKING PROCESS, RESULTED IN THE TUBE BEING OMITTED FROM THE BUBBLE CPAP CIRCUIT KITS. NEW STANDARD OPERATING PROCEDURES HAVE BEEN PUT IN PLACE TO ASSIST THE OPERATORS ON THE PRODUCTION LINE TO CORRECTLY PACK THE CIRCUIT KITS. A SPECIFIC PACK CARD DETAILING ALL COMPONENTS REQUIRED MUST BE DISPLAYED AT THE PACKING STATION. THE BUBBLE CPAP CIRCUIT KITS ARE VISUALLY INSPECTED FOR MISSING COMPONENTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO BREATHING CIRCUITS FROM BC151-10 BUBBLE CPAP KITS HAD MISSING TUBING. ONE KIT WAS MISSING THE EXPIRATORY LIMB AND ONE KIT WAS MISSING THE BLUE INSPIRATORY EXTENSION TUBING. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUBBLE CPAP SYSTEM BTT BTT FISHER & PAYKEL HEALTHCARE LTD BC151-10 120806

    Patients

    Seq Age Sex Outcome Treatment
    1