BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3361564 · Received September 21, 2013

    Report

    Report Number
    9611451-2013-00702
    Event Type
    Malfunction
    Date Received
    September 21, 2013
    Date of Event
    August 22, 2013
    Report Date
    August 23, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES RETURNED: RT236 LOT 130424. RT236 LOT UNKNOWN. METHOD: THE COMPLAINT RT236 INFANT BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THEY WERE VISUALLY INSPECTED, PRESSURE TESTED AND SUBSEQUENTLY SUBMERGED IN A WATER BATH TO TEST FOR LEAK. RESULTS: VISUAL INSPECTION OF THE RT236 FROM LOT 130424 REVEALED A HOLE APPROXIMATELY 116 CM FROM THE PROXIMAL CONNECTOR ON THE EVAQUA EXPIRATORY LIMB. VISUAL INSPECTION OF THE OTHER RT236 REVEALED A HOLE APPROXIMATELY 15 CM FROM THE PROXIMAL CONNECTOR ON THE EVAQUA EXPIRATORY LIMB. BOTH CIRCUITS EXHIBITED LEAK AND WERE OUT OF SPECIFICATION. THE WATER BATH TESTS SHOWED THE SOURCE OF THE LEAK TO BE THE PUNCTURED HOLE IN THE EXPIRATORY LIMBS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130424. CONCLUSION: THE DAMAGE TO THE EVAQUA EXPIRATORY LIMBS INDICATES THAT THEY WERE PUNCTURED BY A BLUNT OBJECT. ALL RT236 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAK PRIOR TO DISTRIBUTION. ANY BREATHING CIRCUIT WHICH DOES NOT PASS THE PRESSURE TEST IS DISCARDED. THE SUBJECT RT236 INFANT BREATHING CIRCUITS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THIS SUGGESTS THAT THE AFFECTED BREATHING CIRCUIT WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. THE EXPIRATORY TUBE OF EVAQUA CIRCUITS IS COMPOSED OF A THIN, SEMI-PERMEABLE FILM SPECIALLY DESIGNED TO ALLOW WATER VAPOR FROM EXPIRED VENTILATORY GASES TO PASS THROUGH. THIS TECHNOLOGY WAS DEVELOPED TO OVERCOME CONDENSATE-RELATED ISSUES ASSOCIATED WITH CONVENTIONAL BREATHING CIRCUITS. THE EXPIRATORY TUBE OF AN EVAQUA BREATHING CIRCUIT INCORPORATES A PROTECTIVE MESH TO PREVENT DAMAGE TO THE WALLS OF THE TUBE DURING USE. NONETHELESS, THE EVAQUA TUBING REMAINS MORE SUSCEPTIBLE TO DAMAGE THAN CONVENTIONAL CIRCUITS WHEN EXPOSED TO ROUGH HANDLING OR TO DAMAGE CAUSED BY SHARP OBJECTS AND CIRCUIT HANGERS. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT236 INFANT BREATHING CIRCUIT STATE THE FOLLOWING: - "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." - "USE CAUTION WHEN POSITIONING THE CIRCUIT. SHARP OR HARSH EDGES AND SURFACES MAY DAMAGE THE EXPIRATORY LIMB." - "SET APPROPRIATE VENTILATOR ALARMS."

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT A HOLE WAS FOUND IN THE EXPIRATORY LIMB OF TWO RT236 INFANT DUAL HEATED EVAQUA BREATHING CIRCUITS. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478647 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT236 130424

    Patients

    Seq Age Sex Outcome Treatment
    1