BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2874832 · Received December 16, 2012

    Report

    Report Number
    9611451-2012-00905
    Event Type
    Malfunction
    Date Received
    December 16, 2012
    Report Date
    November 13, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS NOT EXPECTED TO BE RETURNED TO FPH FOR INSPECTION. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HEALTHCARE FACILITY IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE EVENT AS REPORTED. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE COMPLETED OUR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4).THE FPH FIELD REPRESENTATIVE ATTEMPTED TO OBTAIN THE COMPLAINT RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT FOR FURTHER INVESTIGATION BUT WAS INFORMED BY THE HEALTHCARE FACILITY THAT IT HAD BEEN DISCARDED. HE ALSO ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED COMPLAINT BUT HE ONLY RECEIVED LIMITED INFORMATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE EVENT DESCRIPTION, LIMITED INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, AND OUR KNOWLEDGE OF THE PRODUCT. THE HEALTHCARE FACILITY REPORTED THAT THE SUBJECT BREATHING CIRCUIT PASSED THE PRESSURE AND LEAK TEST BEFORE IT WAS CONNECTED TO A PATIENT. IT WAS FURTHER REPORTED THAT THE INSPIRATORY AND THE EXPIRATORY LIMBS WERE NOT STRETCHED DURING USE BUT COULD NOT BE CONFIRMED IF THEY HAD BEEN PULLED AWAY FROM THE SWIVEL Y-PIECE. A LOT CHECK WAS NOT PERFORMED AS LOT INFORMATION WAS NOT PROVIDED. WITHOUT THE COMPLAINT DEVICE AND SUFFICIENT INFORMATION FROM THE HEALTHCARE FACILITY, WE WERE UNABLE TO CONCLUDE DEFINITIVELY THE ROOT CAUSE OF THE REPORTED FAULT. ALL INFANT BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS, AND VISUALLY INSPECTED FOR DEFECTS SUCH AS CRACKS, TEARS AND DEFORMATION PRIOR TO LEAVING THE PRODUCTION LINE. THOSE THAT FAIL ARE REJECTED. ALL INFANT BREATHING CIRCUITS ARE ALSO SHIPPED TO THE CUSTOMER FULLY ASSEMBLED WITH ONE END OF THE INSPIRATORY AND THE EXPIRATORY LIMBS FULLY INSERTED INTO THE SWIVEL Y-PIECE, HAVING A STANDARD CONNECTION OF 1 IN 40 MEDICAL TAPER-FIT. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS."

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE SWIVEL Y-PIECE BECAME DISCONNECTED FROM THE INSPIRATORY AND EXPIRATORY LIMBS OF AN RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE SWIVEL Y-PIECE BECAME DISCONNECTED FROM THE INSPIRATORY AND EXPIRATORY LIMBS OF AN RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1