BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2638047 · Received July 2, 2012

    Report

    Report Number
    9611451-2012-00430
    Event Type
    Malfunction
    Date Received
    July 2, 2012
    Date of Event
    June 5, 2012
    Report Date
    June 5, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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). THE COMPLAINT DEVICES ARE CURRENTLY ON THEIR WAY TO FISHER & PAYKEL HEALTHCARE. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FIVE COMPLAINT BREATHING CIRCUITS WERE RECEIVED: TWO FROM LOT 110725, AND ONE EACH FROM LOTS 110521, 110525 AND 110908. THE RETURNED COMPLAINT CIRCUITS WERE PRESSURE TESTED TO CHECK IF THERE WAS A LEAK OR IF THE CONNECTIONS WOULD BECOME LOOSE WHEN THE CIRCUIT WAS PRESSURISED. RESULTS:. ONE CIRCUIT FROM LOT 110725 EXHIBITED LEAK AT THE SWIVEL WYE DURING THE PRESSURE TEST. CLOSER INSPECTION REVEALED DAMAGE IN A SECTION OF THE SEALING AREA OF THE SWIVEL. A WATER BATH TEST SHOWED THE LOCATION OF THE LEAK TO BE IN THE DAMAGED SEALING AREA OF THE SWIVEL WYE. THIS WAS SHOWN BY A STRONG FORMATION OF BUBBLES AROUND THE DAMAGED AREA. IN ALL FOUR OF THE OTHER RETURNED CIRCUITS THE INSPIRATORY AND EXPIRATORY LIMBS WERE ABLE TO BE TIGHTLY FITTED TO THE SWIVEL. THERE WAS NO LOOSENESS NOTED IN THE CONNECTION. THE PRESSURE TEST REVEALED THAT THE FOUR SWIVELS WERE WITHIN SPECIFICATION, AND NO FAULT WAS FOUND WITH THEM. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THE LOT NUMBERS PROVIDED. CONCLUSION: IN THE CASE OF THE CIRCUITS THAT WERE WITHIN SPECIFICATION WE ARE UNABLE TO DETERMINE WHAT HAD CAUSED THE SWIVEL TO DETACH FROM THE EXPIRATORY LIMB AS REPORTED BY THE CUSTOMER, AS ALL CONNECTIONS WERE A TIGHT FIT AND DID NOT LOOSEN UNDER PRESSURE. IN THE CASE OF THE LEAKING SWIVEL IT COULD NOT BE DETERMINED HOW THE SWIVEL CAME TO BE DAMAGED. ALL CIRCUITS ARE PRESSURE TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCTION LINE. THIS IS AN AUTOMATED PROCESS AND ANY LEAK IN THE SYSTEM FROM LOOSE CONNECTIONS WOULD HAVE BEEN DETECTED BY THE AUTOMATIC LEAK AND FLOW TESTER ON THE PRODUCTION LINE. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE TWO PARTS OF THE SWIVEL Y-PIECE ON THE RT235 INFANT BREATHING CIRCUIT COME APART EASILY. THEY FURTHER STATED THAT THE SWIVEL HAD NOT COME APART WHILE IN USE ON PATIENTS, BUT WAS NOTICED DURING AN INITIAL SETUP.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE TWO PARTS OF THE SWIVEL Y-PIECE ON THE RT235 INFANT BREATHING CIRCUIT COME APART EASILY. THEY FURTHER STATED THAT THE SWIVEL HAD NOT COME APART WHILE IN USE ON PATIENTS, BUT WAS NOTICED DURING AN INITIAL SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT235 110521

    Patients

    Seq Age Sex Outcome Treatment
    1