BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE ADULT BREATHING CIRCUIT

    MDR report key: 4544370 · Received February 25, 2015

    Report

    Report Number
    9611451-2015-00103
    Event Type
    Malfunction
    Date Received
    February 25, 2015
    Date of Event
    January 20, 2015
    Report Date
    January 27, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K131957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT FIVE BREATHING CIRCUITS (1 X LOT 140404, MANUFACTURED 4 APRIL 2014; 1 X LOT 140708, MANUFACTURED 8 JULY 2014; 1 X LOT 140721, MANUFACTURED 21 JULY 2014; 2 X LOT UNKNOWN) WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. A WATER BATH TEST WAS PERFORMED TO DETECT LEAKS IN THE BREATHING CIRCUITS. THE CIRCUITS WERE VISUALLY INSPECTED, MEASURED FOR BEAD WIDTH, BEAD HEIGHT AND FILM THICKNESS. RESULTS: THE WATER BATH TEST REVEALED THAT ONE OF THE FIVE CIRCUITS WAS LEAKING BETWEEN THE CHAMBER CUFF AND BREATHABLE FILM AND HAD NO OBVIOUS PHYSICAL DAMAGE. VISUAL INSPECTION OF THE OTHER FOUR CIRCUITS REVEALED A TORN FILM IN THE HEATED TUBE. THE SMALLEST TEAR WAS FOUND TO BE APPROXIMATELY 13 MM AND THE BIGGEST TEAR WAS APPROXIMATELY 23 MM. THE TEAR IN THE TUBING FILM WAS FOUND FOR THREE CIRCUITS AT THE PATIENT END OVER-MOULDED CUFF AND FOR ONE CIRCUIT AT THE CHAMBER END OVERMOULDED CUFF. THESE FOUR TORN CIRCUITS HAD A MEASURED BEAD WIDTH AND BEAD HEIGHT WITHIN SPECIFICATION AND ALSO THE FILM THICKNESS WAS WITHIN SPECIFICATION. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT HAD CAUSED THE OBSERVED DAMAGE. THE CUSTOMER HAD REPORTED THAT THE CIRCUITS WERE IN USE FOR ABOUT THREE DAYS AND HAD ALL BEEN PASTEURIZED AND REUSED AT LEAST THREE TIMES, WHICH INDICATES THAT THE CIRCUITS BECAME DAMAGED DURING USE. OUR USER INSTRUCTIONS THAT ACCOMPANY THE (B)(4) REUSABLE BREATHING CIRCUIT CONTAIN THE FOLLOWING WARNINGS: CLEAN CIRCUIT PRIOR TO USE AND AFTER EACH PATIENT USE, USING APPROVED DISINFECTION METHODS ONLY. USE OF UNAPPROVED CLEANING METHODS MAY DAMAGE THE CIRCUIT AND REDUCE IT USEABLE LIFE. INSPECT CIRCUIT BEFORE RE-USE, DO NOT USE IF THE CIRCUIT SHOWS SIGN OF DETERIORATION, SUCH AS CRACKS, TEARS OR DAMAGE. DISCONNECT TUBE BY HANDLING END CONNECTORS ONLY, DO NOT PULL OR TWIST TUBING, AS THIS MAY CAUSE DAMAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIVE COMPLAINT BREATHING CIRCUITS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT FIVE 900MR810 REUSABLE ADULT BREATHING CIRCUITS WERE BROKEN NEAR THE CHAMBER SIDE DURING USE. IT WAS FURTHER REPORTED THAT FOUR OF THESE FIVE CIRCUITS WERE BROKEN AFTER TWO DISINFECTION CYCLES AND THAT THE TIDAL VOLUME OF THE PATIENT WAS DROPPING WHEN THEY WERE USING THE VENTILATOR PB840 WITH THE CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT FIVE 900MR810 REUSABLE ADULT BREATHING CIRCUITS WERE BROKEN NEAR THE CHAMBER SIDE DURING USE. IT WAS FURTHER REPORTED THAT FOUR OF THESE FIVE CIRCUITS WERE BROKEN AFTER TWO DISINFECTION CYCLES AND THAT THE TIDAL VOLUME OF THE PATIENT WAS DROPPING WHEN THEY WERE USING THE VENTILATOR PB8400 WITH THE CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132923 REUSABLE ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD 900MR810 140404

    Patients

    Seq Age Sex Outcome Treatment
    1 VENTILATOR PB8400| VENTILATOR PB8400