BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 5009031 · Received August 17, 2015

    Report

    Report Number
    9611451-2015-00357
    Event Type
    Malfunction
    Date Received
    August 17, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 22, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: 150306, MANUFACTURING DATE: 03/06/2015, QUANTITY AFFECTED: 1. LOT NUMBER: 150402, MANUFACTURING DATE: 04/02/2015, QUANTITY AFFECTED: 1. ONE OF THE COMPLAINT RT125 INFANT BIAS FLOW BREATHING CIRCUITS IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: MANUFACTURING DATE: QUANTITY AFFECTED: 150306, 03/06/2015, 1; 150402, 04/02/2015, 1; METHOD: ONE RT125 INFANT BIAS FLOW BREATHING CIRCUIT, WITH UNKNOWN LOT NUMBER, WAS RETURNED TO FPH IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED BREATHING CIRCUIT. THE PRESSURE TEST RESULT WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 150306 AND 150402. CONCLUSION: THE LEAK REPORTED BY THE DISTRIBUTOR WAS NOT REPLICATED DURING INSPECTION. WE ARE THEREFORE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE REPORTED PROBLEM. ALL RT125 INFANT BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED PRIOR TO DISTRIBUTION, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT RT125 INFANT BREATHING CIRCUITS WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THIS SUGGESTS THE LEAK OCCURRED POST PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT125 INFANT BIAS FLOW 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."

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT125 INFANT BIAS FLOW BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WERE INFORMED THAT IT WAS LOST IN TRANSIT TO (B)(4). WITHOUT THE COMPLAINT DEVICE, WE WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAULT. IF THE COMPLAINT DEVICES WERE RETURNED, IT WOULD HAVE BEEN VISUALLY INSPECTED AND PRESSURE TESTED TO CONFIRM THE REPORTED LEAK. ALL INFANT BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT INFANT BREATHING CIRCUITS WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT125 INFANT BIAS FLOW 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 DISTRIBUTOR IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT TWO RT125 INFANT BIAS FLOW BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT TWO RT125 INFANT BIAS FLOW BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT TWO RT125 INFANT BIAS FLOW BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543319 INFANT BIAS FLOW BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT125 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1