BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT

    MDR report key: 2720099 · Received August 29, 2012

    Report

    Report Number
    9611451-2012-00582
    Event Type
    Malfunction
    Date Received
    August 29, 2012
    Date of Event
    July 29, 2012
    Report Date
    July 31, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BACKGROUND: THE T-PIECE CIRCUIT ((B)(4)) IS DESIGNED TO BE USED FOR INFANT RESUSCITATION TO DELIVER APPROPRIATE POSITIVE END EXPIRATORY PRESSURE (PEEP) AND POSITIVE INSPIRATORY PRESSURE (PIP) PRESSURES WHEN USED WITH A FLOW RATE OF 5 TO 15 LPM. IT IS USED BY CONNECTING TO THE NEOPUFF INFANT RESUSCITATOR (RD900 SERIES). METHOD: THE COMPLAINT T-PIECE CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) FOR EVALUATION. THE RETURNED T-PIECE CIRCUIT WAS VISUALLY INSPECTED AND WAS CONNECTED TO A FPH NEOPUFF INFANT RESUSCITATOR, AND PEEP PRESSURE TESTED ACCORDING TO THE RECOMMENDED SETTINGS IN THE NEOPUFF TECHNICAL MANUAL. RESULTS: VISUAL INSPECTION REVEALED NO DAMAGE TO THE RETURNED T-PIECE CIRCUIT OR TO THE FUNCTION OF THE PEEP CAP. THE PEEP READINGS OF THE COMPLAINT T-PIECE CIRCUIT WERE WITHIN THE REQUIRED SPECIFICATION AND THE DEVICE FUNCTIONED AS INTENDED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120426. CONCLUSION: NO FAULT WAS OBSERVED WITH THE RETURNED T-PIECE CIRCUIT WHEN VISUALLY INSPECTED AND PRESSURE TESTED. IN ORDER TO MINIMISE INADVERTENT ADJUSTMENT OF THE PEEP CAP, A TENSION SPRING HAS BEEN DESIGNED INTO THE T-PIECE. SINCE RECEIVING THE COMPLAINT, AN FPH CLINICAL REPRESENTATIVE HAS VISITED THE HOSPITAL TO PROVIDE SUPPORT AND ANSWER ANY QUESTIONS. THE HOSPITAL IS CONTINUING TO USE THE NEOPUFF RESUSCITATOR WITH THE T-PIECE CIRCUIT ON A REGULAR BASIS WITHOUT ANY FURTHER ISSUES. OUR USER INSTRUCTIONS THAT ACCOMPANY EACH T-PIECE CIRCUIT STATE THE FOLLOWING: "CONNECT THE TEST LUNG TO THE T-PIECE CIRCUIT AND TEST RESUSCITATOR FUNCTION BEFORE CONNECTING TO THE PATIENT" "THE T-PIECE CIRCUIT AND NEOPUFF ARE INTENDED FOR USE BY ADEQUATELY TRAINED MEDICAL PRACTITIONERS" "THE T-PIECE CIRCUIT IS ONLY TO BE USED WITH A FLOW RATE FROM 5-15 L/MIN."

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HOSPITAL IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE PEEP ADJUSTMENT VALVE OF A RESUSCITATION KIT CAME OFF THE T-PIECE CIRCUIT WHILE RESUSCITATING A PATIENT. AN ALTERNATIVE T-PIECE CIRCUIT WAS REQUIRED. ON (B)(6) 2012, THE HOSPITAL REPORTED THE EVENT TO THE FDA, VIA UF/IMPORTER REPORT NUMBER (B)(4). IN THEIR REPORT THEY STATED THAT PRIOR TO USING THE T-PIECE CIRCUIT WITH AN FPH NEOPUFF RESUSCITATOR, THE PATIENT HAD MUCOID PLUGS BLOCKING THEIR ENDOTRACHEAL TUBE, CAUSING THE PATIENT TO BECOME BRADYCARDIC AND DESATURATED. THE HOSPITAL FURTHER STATED THAT ONCE A NEW T-PIECE CIRCUIT WAS USED, THE PATIENT RECOVERED AND WAS PLACED BACK ON A VENTILATOR. NO FURTHER PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE PEEP ADJUSTMENT VALVE OF A RESUSCITATION KIT CAME OFF THE T-PIECE CIRCUIT WHILE RESUSCITATING A PATIENT. AN ALTERNATIVE T-PIECE CIRCUIT WAS REQUIRED. ON (B)(6) 2012, THE HOSPITAL REPORTED THE EVENT TO THE FDA, VIA UF/IMPORTER REPORT NUMBER (B)(4). IN THEIR REPORT THEY STATED THAT PRIOR TO USING THE T-PIECE CIRCUIT WITH AN FPH NEOPUFF RESUSCITATOR, THE PATIENT HAD MUCOID PLUGS BLOCKING THEIR ENDOTRACHEAL TUBE, CAUSING THE PATIENT TO BECOME BRADYCARDIC AND DESATURATED. THE HOSPITAL FURTHER STATED THAT ONCE A NEW T-PIECE CIRCUIT WAS USED THE PATIENT RECOVERED AND WAS PLACED BACK ON A VENTILATOR. NO FURTHER PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT BTL BTL FISHER & PAYKEL HEALTHCARE LTD 900RD010 120426

    Patients

    Seq Age Sex Outcome Treatment
    1 FPH NEOPUFF RESUSCITATOR| FPH NEOPUFF RESUSCITATOR