BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE CPAP SYSTEM

    MDR report key: 2878618 · Received December 18, 2012

    Report

    Report Number
    9611451-2012-00916
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 16, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K100011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE BC160-10 BUBBLE CPAP SYSTEM IS DESIGNED FOR USE WITH SPONTANEOUSLY BREATHING INFANTS WHO REQUIRE CPAP THERAPY. WHEN QUESTIONED ABOUT THEIR INITIAL STATEMENT REGARDING REUSE OF THE BREATHING CIRCUITS, THE HOSPITAL SUBSEQUENTLY STATED THAT THE SINGLE USE BREATHING CIRCUIT WAS NOT REUSED. FISHER AND PAYKEL HEALTHCARE (FPH) SOUGHT BUT DID NOT RECEIVE CONFIRMATION OF THE PATIENT'S STATUS FOLLOWING THE ALLEGED INCIDENT. THE FOLLOWING COMPLAINT DEVICES AND OTHER COMPONENTS IN THE SET-UP WERE RETURNED TO FPH FOR INVESTIGATION: 1X MR850 HUMIDIFIER SN (B)(4), 1X MR290 CHAMBER, 1X BC100 CPAP GENERATOR AND CPAP PROBE, 1X BC161 EXPIRATORY LIMB, 1X BC18/BC19 INFANT NASAL TUBING, 1X (B)(4) HEATER WIRE ADAPTOR LOT 090706, 1X (B)(4) TEMPERATURE/FLOW PROBE, LOT 111129. THE INSPIRATORY LIMB AND HEATER WIRE WERE NOT RECEIVED FOR INVESTIGATION. METHOD: THE DEVICES WERE ALL VISUALLY INSPECTED. IN ADDITION, THE MR850 WAS POWERED ON TO CHECK THE LAST ALARM STATE AND LAST FAULT STATE AND WAS PERFORMANCE TESTED. RESULTS: ALL THE DEVICES APPEARED TO HAVE SUSTAINED SOME DEGREE OF FIRE OR SMOKE DAMAGE. MR850 RESPIRATORY HUMIDIFIER: THE REAR AND LEFT SIDE OF THE ENCLOSURE HAD SUSTAINED HEAT DAMAGE. THERE WAS NO POWER PLUG ATTACHED TO THE POWER CORD. THE LAST FAULT STATE RECORDED IN THE DEVICE MEMORY WAS E13. THE ERROR CODE E13 TELLS US THAT THE TEMPERATURE CIRCUIT CALIBRATION IS OUT OF RANGE. IN THIS CASE THE E13 ERROR WOULD HAVE BEEN GENERATED AS A RESULT OF THE FIRE DAMAGE TO THE TEMPERATURE PROBE CABLE. THE MR850 PASSED ALL CALIBRATION AND PERFORMANCE CHECKS AND WAS TEST RUN FOR TWO HOURS WITH NO ERRORS. MR290 CHAMBER: THE CHAMBER WAS EXTENSIVELY FIRE DAMAGED, WITH THE INLET AND OUTLET PORTS AND CHAMBER DOME MELTED, AND THE WATER FEED SET DETACHED FROM THE CHAMBER. BC100 CPAP GENERATOR, CPAP PROBE AND BC161 EXPIRATORY LIMB HAD ALL SUSTAINED SMOKE DAMAGE. INFANT NASAL TUBING: THIS PRODUCT HAS BEEN MODIFIED. THERE SHOULD HAVE BEEN TWO TUBES CONNECTED TO THE TRILUMEN TUBE OPPOSITE WHERE THE MASK OR PRONG IS FITTED.THE BLUE INSPIRATORY COLLAPSIBLE HAS BEEN REMOVED ALTOGETHER SO THAT THE TEMPERATURE PROBE HOUSING COULD BE CONNECTED DIRECTLY INSTEAD. ADDITIONALLY, THE RETURNED TUBING IS AN OLD MODEL; THIS WAS REPLACED BY THE CURRENT FLEXITRUNK MODEL, WHICH WAS INTRODUCED ON 4 NOVEMBER 2010; (B)(4) HEATER WIRE ADAPTOR: THE HEATER WIRE ADAPTOR IS DESIGNED TO CONNECT A HEATED BREATHING CIRCUIT TO THE HUMIDIFIER. VISUAL INSPECTION REVEALED THAT THERE WAS NO DAMAGE BUT THE DEVICE WAS COVERED IN SOOT. THE INSPIRATORY LIMB HEATER WIRE SOCKET WAS STILL ATTACHED TO THE HEATER WIRE ADAPTOR; (B)(4) TEMPERATURE FLOW PROBE: THE TEMPERATURE FLOW PROBE CONSISTS OF SEPARATE CHAMBER AND PATIENT/AIRWAY THERMISTORS. IT IS INSERTED INTO THE BREATHING CIRCUIT SYSTEM TO MONITOR TEMPERATURE AND FLOW OF VENTILATORY GASES AT EACH END OF THE BREATHING CIRCUIT. THE PROBE RELAYS THIS INFORMATION BY WAY OF ELECTRICAL FEEDBACK TO THE HUMIDIFIER. INSPECTION REVEALED THAT THE PROBE WAS EXTENSIVELY FIRE DAMAGED, AND THAT THE CHAMBER FLOW PROBE WAS BURNT AND FUSED TO THE LEFT SIDE OF THE MR850'S ENCLOSURE. WE WERE UNABLE TO IDENTIFY THE MANUFACTURER OR MAKE OF THE INSPIRATORY LIMB OR HEATER WIRE. CONCLUSION/COMMENTS: AS THE COMPLAINT INSPIRATORY LIMB AND HEATER WIRE WERE NOT RECEIVED FOR INVESTIGATION, FPH IS UNABLE TO CONCLUSIVELY DETERMINE THE POTENTIAL ROOT CAUSE OF THIS INCIDENT.. THE NATURE OF THE DAMAGE WE OBSERVED ON THE COMPONENTS THAT WERE RECEIVED SUGGESTS THAT THE LIKELY SOURCE OF THE FIRE IS IN THE VICINITY OF THE HEATER WIRE / INSPIRATORY LIMB, AS THE AREAS SURROUNDING THESE COMPONENTS (SPECIFICALLY THE CHAMBER AND THE PROBE) DISPLAYED THE GREATEST CONCENTRATION OF HEAT DAMAGE. WE NOTE THAT THE CHAMBER HAS NO HEAT SOURCE AND THE PROBE IS INSULATED AND DOES NOT GENERATE SUFFICIENT HEAT TO START A FIRE. THE HOSPITAL INITIALLY STATED THAT THEY BELIEVED THAT THE CAUSE OF THE FIRE WAS THE REUSE OF DISPOSABLE CIRCUITS. UPON FURTHER QUESTIONING, THIS STATEMENT WAS RETRACTED. WE NOTE THAT THE NASAL TUBING HAD BEEN MODIFIED AND THAT IT WAS MANUFACTURED BEFORE NOVEMBER 2010. THE USER INSTRUCTIONS THAT ACCOMPANY THE BC161 BUBBLE CPAP SYSTEM CONTAIN THE FOLLOWING WARNING: "DO NOT REUSE ANY PART OF THE BC151 OR BC161. IT IS MANUFACTURED FOR SINGLE PATIENT USE ONLY. REUSE MAY RESULT IN TRANSMISSION OF INFECTIOUS SUBSTANCES, INTERRUPTION TO TREATMENT, SERIOUS HARM OR DEATH." THE USER INSTRUCTIONS ALSO SPECIFY THE FOLLOWING STATEMENTS TO WARN THE USER AGAINST POTENTIAL OVERHEATING: CHECK THAT THE HEATER WIRE IS EVENLY DISTRIBUTED ALONG THE BLUE INSPIRATORY TUBE AND IS NOT BUNCHED OR KINKED. DO NOT SOAK, WASH, STERILIZE OR RE-USE THIS PRODUCT; DO NOT COVER THE CIRCUIT WITH MATERIALS SUCH AS BLANKETS, TOWELS OR BED LINEN; DO NOT STRETCH OR MILK THE TUBING.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A BC161-10 BUBBLE CPAP SYSTEM HAD "BURNT" AND THAT THEY BELIEVED IT WAS DUE TO THE REUSE OF DISPOSABLE CIRCUITS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUBBLE CPAP SYSTEM BTT BTT FISHER & PAYKEL HEALTHCARE LTD BC161-10 091119

    Patients

    Seq Age Sex Outcome Treatment
    1 FPH MR850 HUMIDIFIER| FPH (B)(4) HEATER WIRE ADAPTOR| FPH (B)(4) TEMP/FLOW PROBE| FPH MR290 AUTOFEED HUMIDIFICATION CHAMBER