BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT

    MDR report key: 2500781 · Received March 22, 2012

    Report

    Report Number
    9611451-2012-00164
    Event Type
    Injury
    Date Received
    March 22, 2012
    Report Date
    February 22, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTL
    PMA / PMN Number
    K892885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY AWAITING THE RETURN OF THE COMPLAINT DEVICE FOR EVALUATION AT FISHER & PAYKEL HEALTHCARE (B)(4). WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICE AND COMPLETION OF OUR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBERS: 100420 AND 110922. DEVICE MANUFACTURE DATES: 20 APRIL 2010 AND 22 SEPTEMBER 2011. THE 900RD010 SINGLE USE INFANT RESUSCITATION CIRCUIT ASSEMBLY CONSISTS OF A BREATHING TUBE AND A T-PIECE. IT IS INTENDED TO BE CONNECTED TO A FISHER & PAYKEL HEALTHCARE (FPH) RD900 NEOPUFF INFANT RESUSCITATOR AND ALLOWS DELIVERY OF PEAK INSPIRATORY PRESSURE (PIP) AND POSITIVE END EXPIRATORY PRESSURE (PEEP) VIA THE PEEP CAP / VALVE. TWO 900RD010 T-PIECE CIRCUITS WERE RETURNED TO FPH (B)(4) AND THE PEEP FOR BOTH DEVICES WAS PRESSURE TESTED AS PER THE RECOMMENDED SETTINGS IN THE NEOPUFF PRODUCT TECHNICAL MANUAL (PTM) AND THE SETTINGS USED BY THE HOSPITAL. FURTHERMORE, AN ATTEMPT TO REPLICATE THE REPORTED PEEP VALUE (30 CMH20) WAS ALSO PERFORMED WITH A PRESSURE TEST. RESULTS: PRESSURE TEST BASED ON THE RECOMMENDED SETTINGS IN NEOPUFF PTM AND HOSPITAL'S SETTINGS: FOR BOTH SETTINGS, THE RETURNED DEVICES WERE ABLE TO PRODUCE PEEP VALUES AS PER THE PERFORMANCE SPECIFICATIONS IN THE NEOPUFF PRODUCT TECHNICAL MANUAL. PRESSURE TEST TO CONFIRM REPORTED PEEP VALUE: THE PRESSURE TEST REVEALED THAT ONE OF THE RETURNED DEVICES (LOT 100420) WAS ABLE TO PRODUCE THE REPORTED PEEP VALUE (30 CMH20) AT 10LPM OF GAS FLOW, WHICH IS AS PER THE PERFORMANCE SPECIFICATIONS IN THE NEOPUFF PRODUCT TECHNICAL MANUAL. CONCLUSION: NO FAULT WAS FOUND ON THE TWO RETURNED T-PIECE CIRCUITS AS THEY WERE ABLE TO PERFORM AS PER THE PERFORMANCE SPECIFICATIONS. IT IS POSSIBLE TO ACHIEVE A HIGHER PEEP VALUE THAN THE RANGE STATED IN THE NEOPUFF PRODUCT TECHNICAL MANUAL IF REQUIRED BY THE CLINICIAN. PATIENT STATUS: THE HOSPITAL REPORTED THAT THE T-PIECE CIRCUIT WAS CHANGED DURING RESUSCITATION AND THE PEEP OF 30 CMH20 WENT UNNOTICED FOR A PERIOD OF TIME. THERE WAS NO CONFIRMATION THAT THE CORRECT PRESSURE WAS CHECKED PRIOR TO PATIENT USE WHEN THE T-PIECE CIRCUIT WAS REPLACED. PATIENT WAS REPORTED TO HAVE BILATERAL PNEUMOTHORACES, AND REQUIRED HIGH FREQUENCY VENTILATION. THE HOSPITAL WAS NOT ABLE TO CONFIRM IF THE INJURY WAS RELATED TO THE PEEP DELIVERY OF 30 CMH20. NO FURTHER PATIENT INFORMATION WAS PROVIDED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT NUMBERS 100420 AND 110922. THE PEEP CAP OF T-PIECE CIRCUIT IS ADJUSTED DURING USE, DEPENDING ON THE PRESSURE SET BY THE PHYSICIAN. THE USER INSTRUCTIONS (UI) THAT ACCOMPANY THE RD900 NEOPUFF INFANT RESUSCITATOR REMIND THE USER TO ENSURE THAT THE NEOPUFF IS FUNCTIONING CORRECTLY AND THAT THE PEEP CAP IS ADJUSTED TO THE DESIRED PEEP LEVEL PRIOR TO EVERY USE. THE UI ALSO PROVIDE A WARNING "THE NEOPUFF INFANT RESUSCITATOR MUST ONLY BE USED AFTER CHECKING THAT CORRECT PRESSURES WILL BE DELIVERED TO THE BABY". THE 900RD010 T-PIECE CIRCUIT USER INSTRUCTIONS (UI) INDICATE IN PICTORIAL FORM OF THE CORRECT SET-UP, PIP AND PEEP LEVEL ADJUSTMENTS, AND USE OF T-PIECE CIRCUIT BEFORE AND DURING RESUSCITATION. IT ALSO STATES THE FOLLOWING: CONSULT THE ACCOMPANYING DOCUMENTS FOR YOUR T-PIECE RESUSCITATION DEVICE FOR ADDITIONAL USER INSTRUCTIONS AND WARNINGS; CONNECT THE TEST LUNG TO THE T-PIECE CIRCUIT AND TEST RESUSCITATOR FUNCTION BEFORE CONNECTING TO THE PATIENT; ENSURE PRESSURES ARE MONITORED THROUGHOUT RESUSCITATION; THE T-PIECE CIRCUIT AND NEOPUFF ARE INTENDED FOR USE BY ADEQUATELY TRAINED MEDICAL PRACTITIONERS. ALL 900RD010 T-PIECE CIRCUITS ARE VISUALLY INSPECTED AND PERFORMANCE TESTED PRIOR TO LEAVING THE PRODUCTION LINE TO ENSURE THAT THEY MEET THE REQUIRED SPECIFICATIONS, AND THOSE THAT FAIL ARE REJECTED. THE FPH FIELD REPRESENTATIVES HAVE BEEN WORKING WITH THE HOSPITAL TO REMIND THEM OF THE WARNINGS AND RECOMMENDATIONS OUTLINED IN THE USER INSTRUCTIONS OF RD900 NEOPUFF INFANT RESUSCITATOR AND 900RD010 T-PIECE CIRCUIT.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) MARKETING MANAGER THAT A CLASSIC T-PIECE OF AN ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT IS FULLY SCREWED DOWN WHEN FIRST TAKEN OUT OF THE PACKAGING AND PRODUCED "A PRESSURE OF 30 CMH2O AT 10 L/MIN WHEN THE PEEP VALVE ON CLASSIC T-PIECE IS FULLY SCREWED DOWN AND OCCLUDED ON MASK END". PATIENT WAS REPORTED TO HAVE BILATERAL PNEUMOTHORACES, AND REQUIRED HIGH FREQUENCY VENTILATION. NO FURTHER PATIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) MARKETING MANAGER THAT A CLASSIC T-PIECE OF AN ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT IS FULLY SCREWED DOWN WHEN FIRST TAKEN OUT OF THE PACKAGING AND PRODUCED "A PRESSURE OF 30 CMH2O AT 10 L/MIN WHEN THE PEEP VALVE ON CLASSIC T-PIECE IS FULLY SCREWED DOWN AND OCCLUDED ON MASK END". PATIENT WAS REPORTED TO HAVE BILATERAL PNEUMOTHORACES, AND REQUIRED HIGH FREQUENCY VENTILATION. NO FURTHER PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT BTL BTL FISHER & PAYKEL HEALTHCARE LIMITED 900RD010 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention