BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 4937745 · Received July 24, 2015

    Report

    Report Number
    9611451-2015-00325
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 25, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: SIX COMPLAINT RT324 BREATHING CIRCUITS AND ONE DRYLINE WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4). FIVE CIRCUITS WERE RETURNED IN THE SEALED PLASTIC BAG AND THE OTHER REMAINING ONE CIRCUIT AND DRYLINE WERE RETURNED IN AN UNSEALED PLASTIC BAG. THE CIRCUITS WERE VISUALLY INSPECTED AND SUBSEQUENTLY SUBMERGED IN A WATER BATH TO DETERMINE THE LOCATION OF THE LEAK. RESULTS: VISUAL INSPECTION OF THE RETURNED DRYLINES REVEALED THAT THE DISTAL CORRUGATION ON THE TUBE OF SIX DRYLINES APPEARED TO HAVE BEEN COMPRESSED AND PINCHED. THERE WAS A PIN-SIZED HOLE NEXT TO THE COMPRESSED PART OF THE CORRUGATION. ADDITIONALLY, FIVE CIRCUITS SHOWED STRESS MARKS ON THE CHAMBER END CONNECTOR. THE WATER BATH TEST SHOWED BUBBLES FORMING FROM THE PIN-SIZED HOLE OF THE COMPLAINT SIX DRYLINES. NO DAMAGE WAS FOUND TO ONE OF THE RETURNED COMPLAINT RT324 CIRCUITS IN THE SEALED PLASTIC BAG. THE PRESSURE TEST REVEALED THAT THE TESTED CIRCUIT WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS NATURE FOR LOT 141129. CONCLUSION: WE ARE UNABLE TO ACCURATELY DETERMINE WHAT MAY HAVE CAUSED THE DAMAGE OBSERVED ON THE RETURNED DRYLINE TUBES. BASED ON OUR FINDINGS FROM INVESTIGATIONS INTO SIMILAR COMPLAINTS, IT IS POSSIBLE THAT THE DAMAGE TO THE RT324 DRYLINE TUBES COULD HAVE BEEN CAUSED DURING THE MANUFACTURING PROCESS. DURING THE PRODUCTION OF THE SUBJECT DRYLINE TUBES, A PRESSURE TEST IS PERFORMED EVERY 10 TO 15 MINUTES AND THOSE THAT FAIL ARE SET ASIDE FOR FURTHER INSPECTION. SINCE THEN A 100% LEAK TEST WAS IMPLEMENTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT324 STATE: PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. SET APPROPRIATE VENTILATOR ALARMS. THE HOSPITAL CORRECTLY TESTED THE CIRCUITS PRIOR TO PATIENT USE, WHICH IS IN LINE WITH OUR USER INSTRUCTIONS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT EIGHT RT324 INFANT CONTINUOUS FLOW BREATHING CIRCUITS FAILED THE LEAK TEST. IT WAS REPORTED THAT THE CIRCUITS HAD A HOLE NEAR THE CHAMBER CONNECTOR. THIS WAS FOUND BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483792 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT324 141129

    Patients

    Seq Age Sex Outcome Treatment
    1