BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2582335 · Received May 21, 2012

    Report

    Report Number
    9611451-2012-00321
    Event Type
    Malfunction
    Date Received
    May 21, 2012
    Report Date
    April 27, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE OF THE COMPLAINT RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONE OF THE COMPLAINT RT340 ADULT EVAQUA BREATHING CIRCUITS WAS RETURNED TO FPH IN (B)(4) FOR INSPECTION. THE EVAQUA EXPIRATORY TUBE WAS PRESSURE TESTED AND VISUALLY INSPECTED. RESULTS:THE PRESSURE TEST RESULT WAS OUTSIDE OF THE REQUIRED SPECIFICATION. FURTHER INSPECTION REVEALED THAT THE EXPIRATORY TUBE WAS PUNCTURED ABOUT 4CM FROM THE PATIENT END CONNECTOR. A LOT CHECK REVEALED THREE OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110615. CONCLUSION:BASED ON INSPECTION OF THE DAMAGE, IT IS LIKELY THAT THE EVAQUA EXPIRATORY TUBE WAS PUNCTURED OR SCRATCHED WITH A BLUNT OBJECT. ALL RT340 ADULT BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE BREATHING CIRCUIT WAS DAMAGED POST-PRODUCTION. (B)(4). THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 BREATHING CIRCUIT STATE: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS." "FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT FOUR RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS EACH HAD A HOLE IN THE EXPIRATORY LIMB. IT WAS FURTHER REPORTED THAN AN ERROR MESSAGE "LEAK" APPEARED ON THE EVITA 4 VENTILATOR DURING TESTING OF THE BREATHING CIRCUITS. THIS WAS OBSERVED 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 FOUR RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS EACH HAD A HOLE IN THE EXPIRATORY LIMB. IT WAS FURTHER REPORTED THAT AN ERROR MESSAGE "LEAK" APPEARED ON THE EVITA 4 VENTILATOR DURING TESTING OF THE BREATHING CIRCUITS. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 110615

    Patients

    Seq Age Sex Outcome Treatment
    1