BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 1888644 · Received November 2, 2010

    Report

    Report Number
    9611451-2010-00658
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Report Date
    October 7, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUITS HAVE ONLY RECENTLY BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE AND ARE CURRENTLY BEING INVESTIGATED. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURE DATE: QUANTITY: 7 LOT #: 100608 MANUFACTURE DATE: 06/08/2010; 2, 100614; 06/14/2010; 1, 100504; 05/04/2010; 5, NOT PROVIDED; LOT NUMBER NOT PROVIDED. METHOD: OF THE 15 REPORTED COMPLAINT RT236 INFANT BREATHING CIRCUIT KITS, 10 WERE RETURNED TO FPH (B)(4) FOR INVESTIGATION. SIX OF THE RETURNED BREATHING CIRCUIT KITS (FIVE WITH LOT NUMBER 100608 AND ONE WITH LOT NUMBER 10054) WERE RECEIVED UNSEALED. NO LOT NUMBER WAS PROVIDED FOR THE OTHER FOUR BREATHING CIRCUIT KITS THAT WERE RETURNED LOOSE AND MIXED IN A BOX. ALL RETURNED BREATHING CIRCUITS WERE VISUALLY INSPECTED FOR DAMAGE AND PRESSURE TESTED FOR LEAKS. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED WITH THE RETURNED BREATHING CIRCUITS. THE PRESSURE TEST REVEALED THAT ALL 10 SWIVEL Y-PIECE COMPONENTS WERE OUTSIDE THE REQUIRED SPECIFICATION. UPON SUBMERSION IN A WATER BATH LEAKS WERE DETECTED AROUND THE SWIVEL Y-PIECE COMPONENTS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100504. A LOT CHECK REVEALED SIX OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100608. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 100614. CONCLUSION: THE LEAK WAS CAUSED BY AN INSUFFICIENT SEAL BETWEEN THE TWO PARTS OF THE SWIVEL Y-PIECE THAT ARE HELD TOGETHER BY A SNAP-FIT. ALL BREATHING CIRCUITS ARE PRESSURE TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE LEAK DEVELOPED POST PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A QUANTITY OF 15 RT236 INFANT DUAL HEATED WITH EVAQUA BREATHING CIRCUITS FAILED THE PRESSURE TEST ON A SERVO-I VENTILATOR. THIS WAS NOTICED BEFORE USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A QUANTITY OF 15 RT236 INFANT DUAL HEATED WITH EVAQUA BREATHING CIRCUITS FAILED THE PRESSURE TEST ON A SERVO-I VENTILATOR. THIS WAS NOTICED BEFORE USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL HEATED WITH EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT236 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1