BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2628444 · Received June 26, 2012

    Report

    Report Number
    9611451-2012-00416
    Event Type
    Malfunction
    Date Received
    June 26, 2012
    Report Date
    June 1, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: LOT: 110521, 110725, 110524; MANUFACTURING DATE: 05/21/2011, 07/25/2011, 05/24/2011; QUANTITY RETURNED TO FPH: 1, 1, 1. METHOD: THREE COMPLAINT RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUITS WERE RETURNED TO FPH IN (B)(4) FOR INSPECTION. THE RETURNED DEVICES WERE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS. RESULTS: NO FAULT WAS FOUND TO THE BREATHING CIRCUITS WITH LOT NUMBERS 110521 AND 110725. THE SUBJECT BREATHING CIRCUITS PASSED BOTH VISUAL INSPECTION AND PRESSURE TEST. VISUAL INSPECTION OF THE BREATHING CIRCUIT WITH LOT NUMBER 110524 REVEALED THAT THE SEAL AREA BETWEEN THE SWIVEL ELBOW AND THE SWIVEL WYE WAS DAMAGED. THE PRESSURE TEST SHOWED THAT THE BREATHING CIRCUIT WAS OUT OF SPECIFICATION DUE TO EXCESSIVE LEAK. WHEN IT WAS IMMERSED IN A WATER BATH, THE LEAK WAS CONFIRMED TO BE IN THE DAMAGED SEAL. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110524. FURTHER LOT CHECKS REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 110521, AND TWO OTHERS FOR LOT NUMBER 110725. CONCLUSION: THE TWO PARTS THAT MAKE UP THE Y-SWIVEL ARE HELD TOGETHER BY A SNAP-FIT, WHICH HAS SOME INHERENT LEAKAGE THAT IS DETECTED AND COMPENSATED FOR BY THE VENTILATOR. ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL REVEALED THAT THE BREATHING CIRCUITS WERE SET UP A NUMBER OF DAYS IN ADVANCE PRIOR TO PATIENT USE. IT IS LIKELY THAT THE SUBJECT BREATHING CIRCUIT WITH LOT NUMBER 110524 MAY HAVE BEEN INADVERTENTLY SUBJECTED TO PHYSICAL FORCE DURING SET UP, CONSEQUENTLY CAUSING THE DAMAGE TO THE SEAL AREA BETWEEN THE SWIVEL ELBOW AND THE SWIVEL WYE, AND RESULTED TO THE REPORTED LEAK. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THERE WAS "A LARGE AIR LEAK" AT THE SWIVEL Y-PIECE OF AN RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT, WHICH WAS OBSERVED DURING CIRCUIT TESTING WITH A VN500 VENTILATOR. IT WAS ALSO REPORTED THAT THE Y-PIECE "EASILY DETACHES" FROM THE REST OF THE BREATHING SYSTEM. THIS WAS NOTICED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THERE WAS "A LARGE AIR LEAK" AT THE SWIVEL Y-PIECE OF AN RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT, WHICH WAS OBSERVED DURING CIRCUIT TESTING WITH A VN500 VENTILATOR. IT WAS ALSO REPORTED THAT THE Y-PIECE "EASILY DETACHES" FROM THE REST OF THE BREATHING SYSTEM. THIS WAS NOTICED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT235 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1