BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT FOR SLE 2000/2000HFO

    MDR report key: 1203447 · Received October 17, 2008

    Report

    Report Number
    9611451-2008-00608
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 18, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE SLE RESTRICTOR WAS TESTED FOR TIGHTNESS OF FIT BY CONNECTING IT TO THE SWIVEL Y-PIECE. THE DIAMETER OF THE TAPERED END OF THE SLE RESTRICTOR, WHICH CONNECTS WITH THE INFANT SWIVEL WAS ALSO MEASURED. RESULTS: THE SLE RESTRICTOR IS INSERTED INTO THE BREATHING CIRCUIT DURING PRODUCTION TO RESTRICT FLOW, WHEN USED WITH THE SLE VENTILATOR. THIS RESTRICTOR WAS EASILY REMOVED FROM THE INFANT SWIVEL. WHEN MEASURED, THE DIAMETER OF THE RESTRICTOR WAS FOUND TO BE SLIGHTLY SMALLER THAN SPECIFICATIONS PROVIDE. WE COULD NOT PERFORM A LOT CHECK AS NO LOT INFO HAS BEEN PROVIDED. CONCLUSION: A MOLDING ERROR CREATED A SLIGHTLY SMALLER SLE RESTRICTOR, CAUSING A LOOSE CONNECTION WITH THE INFANT SWIVEL. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS ON THE PRODUCTION LINE AND THOSE THAT FAIL ARE REJECTED. THE RT127 WOULD HAVE PASSED THE LEAK TEST AT THE TIME OF PRODUCTION. ALTHOUGH SLIGHTLY OUTSIDE SPECIFICATIONS, THE RESTRICTOR IS UNLIKELY TO DISCONNECT FROM THE BREATHING CIRCUIT AS A RESULT. SERVICING AND TESTING OF THE MOLDING TOOL HAS RECENTLY BEEN UNDERTAKEN. ALL SLE RESTRICTORS PRODUCED SINCE THE DATE OF THE CORRECTIVE ACTION HAVE BEEN VERIFIED TO BE WITHIN SPECIFICATIONS. OUR MONITORING AND TRENDING OF EVENTS INVOLVING LOOSE RESTRICTORS ON SLE BREATHING CIRCUITS INDICATES A RATE OF OCCURRENCE OF 235PPM WORLDWIDE IN THE LAST YEAR 2008.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED TO OUR DISTRIBUTOR THAT THE SLE RESTRICTOR FROM AN RT127 INFANT BREATHING CIRCUIT HAD A LOOSE CONNECTION WITH THE INFANT SWIVEL Y-PIECE INTERFACE CONNECTION. THIS WAS DETECTED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT FOR SLE 2000/2000HFO BTT FISHER & PAYKEL HEALTHCARE, LTD. RT127

    Patients

    Seq Age Sex Outcome Treatment
    1