BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-HEATED BREATHING CIRCUIT

    MDR report key: 2172773 · Received July 22, 2011

    Report

    Report Number
    9611451-2011-00427
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 20, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): THE (B)(4) SINGLE-HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. THE COMPLAINT (B)(4) BREATHING CIRCUIT IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE BC060 SINGLE-HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. A FISHER & PAYKEL HEALTHCARE (FPH) SERVICE ENGINEER IN (B)(4) CONTACTED THE HOSPITAL FOLLOWING THE REPORTED INCIDENT AND REQUESTED INFORMATION REGARDING THE DETAILS OF THE COMPLAINT. THE FOLLOWING DEVICES WERE RETURNED TO FPH IN (B)(4) FOR INSPECTION: BC060 SINGLE-HEATED BREATHING CIRCUIT, LOT NUMBER 090110. MR290 HUMIDIFICATION CHAMBER, LOT NUMBER 090109 2112; MR850 RESPIRATORY HUMIDIFIER, SERIAL NUMBER (B)(4); 900MR801 HEATER WIRE ADAPTOR, LOT NUMBER 090112. 900MR869 TEMPERATURE/FLOW PROBE, LOT NUMBER 100212. BC110 PRESSURE MANIFOLD. THE RETURNED DEVICES WERE INVESTIGATED AS FOLLOWS: METHOD: THE RETURNED DEVICES WERE VISUALLY INSPECTED FOR DAMAGE AND THE MR850 RESPIRATORY HUMIDIFIER, 900MR869 TEMPERATURE/FLOW PROBE, AND 900MR801 HEATER WIRE ADAPTOR WERE TESTED FOR FUNCTIONALITY. RESULTS: BC060 SINGLE-HEATED BREATHING CIRCUIT. THE HOSPITAL REPORTED THAT THE PATIENT WAS CONNECTED TO THE BREATHING CIRCUIT FOR 6 CONTINUOUS DAYS. A "WARMER" WAS IN USE WHILE THE BREATHING CIRCUIT WAS CONNECTED TO THE PATIENT. THE LENGTH OF THE INSPIRATORY TUBE OF THE BC060 BREATHING CIRCUIT WAS MEASURED AND FOUND TO BE 1160 MILLIMETRES, WHICH IS WITHIN THE REQUIRED SPECIFICATION. THE HEATER WIRE RETAINER WAS FOUND 190 MILLIMETRES AWAY FROM THE AIRWAY PORT PROBE, WHICH IS OUTSIDE OF SPECIFICATION. FURTHER INSPECTION REVEALED THAT THE INSPIRATORY TUBE WAS MELTED AT THE CHAMBER END. MR290 HUMIDIFICATION CHAMBER: THE CHAMBER DOME WAS NOT DAMAGED BUT THERE WERE SOME DRIED RESIDUES INSIDE. MR850 RESPIRATORY HUMIDIFIER, 900MR801 HEATER WIRE ADAPTOR, 900MR869 TEMPERATURE/FLOW PROBE. NO FAULT WAS FOUND WITH THESE DEVICES. THEY PASSED THE PERFORMANCE CHECKS AND ELECTRICAL SAFETY TESTS. CONCLUSION: BASED ON OUR INSPECTION OF THE RETURNED BREATHING CIRCUIT, BUNCHING OF THE HEATER WIRE COILS RESULTED IN EXCESSIVE LOCALISED HEATING AND DAMAGED TO THE HEATER WIRE INSULATION. WITHOUT INSULATION, IT IS POSSIBLE FOR BARE FILAMENTS OF THE HEATER WIRE TO CONTACT SHORT CIRCUIT, AND CAUSE IGNITION OF THE BREATHING CIRCUIT. HEATER WIRE BUNCHING IS A KNOWN FACTOR LEADING TO CIRCUIT FIRES; HOWEVER, WITH THE LIMITED INFORMATION WE RECEIVED FROM THE HOSPITAL, WE ARE UNABLE TO DETERMINE HOW THE HEATER WIRE BECAME BUNCHED. FPH USER INSTRUCTIONS THAT ACCOMPANY THE BC060 BREATHING CIRCUIT INCLUDE THE FOLLOWING STATEMENTS TO WARN THE USER AGAINST POTENTIAL LOCALISED OVERHEATING: "CHECK THAT THE HEATER WIRE IS EVENLY DISTRIBUTED ALONG THE BLUE INSPIRATORY TUBE AND IS NOT BUNCHED OR KINKED." "DO NOT STRETCH OR MILK THE TUBING." THIS IS THE ONLY COMPLAINT OF THIS NATURE THAT WE RECEIVED IN THE PAST 12 MONTHS TO THE END OF OCTOBER 2011. AN FPH FIELD REPRESENTATIVE HAS CONFIRMED THAT THE HOSPITAL STAFF ARE TRAINED ON THE PROPER SET-UP AND CORRECT USE OF THE FPH BUBBLE CPAP SYSTEM, AND THAT TRAINING IS ALSO BEING CONDUCTED EVERY 6 MONTHS WITH THE HOSPITAL STAFF.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT A FIRE OCCURRED IN A BUBBLE CPAP SET-UP, WHICH INCLUDED A (B)(4) SINGLE-HEATED BREATHING CIRCUIT, (B)(4) RESPIRATORY HUMIDIFIER, (B)(4) AUTOFEED HUMIDIFICATION CHAMBER, (B)(4) TEMPERATURE/FLOW PROBE AND (B)(4) HEATER WIRE ADAPTOR, DURING USE ON AN INFANT. NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT A FIRE OCCURRED IN A BUBBLE CPAP SET-UP, WHICH INCLUDED A BC060 SINGLE-HEATED BREATHING CIRCUIT, MR850AEU RESPIRATORY HUMIDIFIER, MR290 AUTOFEED HUMIDIFICATION CHAMBER, 900MR896 TEMPERATURE/FLOW PROBE AND 900MR801 HEATER WIRE ADAPTOR, DURING USE ON AN INFANT. NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED BC060 090110

    Patients

    Seq Age Sex Outcome Treatment
    1 MR850AEU RESPIRATORY HUMIDIFIER (SN (B)(4))| 900MR869 TEMPERATURE/FLOW PROBE (LOT: 100212)| MR850AEU RESPIRATORY HUMIDIFIER (SN (B)(4))| 900MR869 TEMPERATURE/FLOW PROBE (LOT: 100212)| MR290 HUMIDIFICATIN CHAMBER (LOT: 090109)| 900MR801 HEATER WIRE ADAPTOR (LOT: 090112)| MR290 HUMIDIFICATIN CHAMBER (LOT: 090109)| 900MR801 HEATER WIRE ADAPTOR (LOT: 090112)