BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2657155 · Received July 16, 2012

    Report

    Report Number
    9611451-2012-00466
    Event Type
    Malfunction
    Date Received
    July 16, 2012
    Report Date
    June 19, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: SEVEN COMPLAINT CHAMBERS WERE RECEIVED, SIX FROM LOT 111117 AND ONE FROM LOT 111202, AND WERE VISUALLY INSPECTED. RESULTS: IN ALL SEVEN CHAMBERS, THE CHAMBER DOME HAD PULLED AWAY FROM THE BASE, BELOW ONE OF THE PORTS OF THE CHAMBER, CREATING LEAK. CONCLUSION: THE HOSPITAL HAS INFORMED US THAT THEY ARE USING THE MR290 CHAMBERS WITH A SIPAP VENTILATOR. THIS TYPE OF VENTILATOR IS CAPABLE OF PRODUCING PRESSURES IN EXCESS OF 80CMH2O. THE INTEGRITY OF THE CHAMBER CAN BE AFFECTED WHEN PRESSURES EXCEED 80CMH2O. FOLLOWING THESE COMPLAINTS, FISHER & PAYKEL HEALTHCARE (B)(4), NATIONAL SALES MANAGER AND OUR LOCAL (B)(4) MANAGER VISITED (B)(6) HOSPITAL AND MET WITH (B)(6), (SENIOR CRITICAL CARE TECHNOLOGIST) AND (B)(6) (JUNIOR CRITICAL CARE TECHNOLOGIST) REGARDING THE MR290 CHAMBER LEAKS DURING SIPAP VENTILATION. FROM DISCUSSIONS HELD, IT BECAME CLEAR THAT OCCASIONALLY, DUE TO EXCESSIVE PRESSURE IN THE CHAMBER, THE CHAMBER WOULD "RUN DRY" WHEN THE WATER BAG WAS LESS THAN HALF FULL. EXCESS PRESSURE IN THE CHAMBER WAS CAUSING BACK PRESSURE IN THE WATER FEED SET TUBE, PREVENTING WATER FROM FLOWING DOWN AND ENTERING THE CHAMBER. ONCE THE CHAMBER RAN DRY EXCESS PRESSURE WOULD CAUSE THE DOME TO PULL AWAY FROM THE BASE, CREATING THE LEAK OBSERVED AT THE HOSPITAL. STAFF AT (B)(6) INDICATED THAT THEY ARE HAPPY WITH THE MR290 CHAMBERS, AND HAVE COME UP WITH A SOLUTION OF LOWERING THE HUMIDIFIERS BEING USED WITH THE SIPAP VENTILATORS IN ORDER TO OVERCOME THE CHAMBERS RUNNING DRY. WE KNOW THAT INCREASING THE DISTANCE BETWEEN THE WATER BAG AND THE CHAMBER (THEREBY LENGTHENING THE WATER FEED SET TUBE) HELPS PREVENT THE CHAMBERS FROM RUNNING DRY. INFANT THERAPIES INVOLVING HIGH PRESSURES ARE BECOMING MORE WIDELY USED AND FOR THIS REASON FPH MANUFACTURES A WATER FEED SET EXTENSION, WHICH IS RECOMMENDED FOR USE IN SUCH CASES. THE USER INSTRUCTIONS FOR THE WATER FEED SET EXTENSION, (B)(4), STATE THAT IT "ALLOWS THE MR290 TO BE USED WITH INFANT CPAP SYSTEMS." AS OF 8 MAY 2012 ALL SIPAP VENTILATORS AT THE HOSPITAL HAVE HAD THE HUMIDIFIERS ON THEM LOWERED BY ABOUT 30CM. THE CRITICAL CARE UNIT WAS OFFERED OUR WATER FEED SET EXTENSIONS AND ARE USING THEM ON A REGULAR BASIS NOW. FOLLOWING THIS COMPLAINT, THE HOSPITAL HAS REPORTED THAT THEY ARE CONTINUING TO WORK TO RAISE THE HEIGHT OF THE WATER BAGS BY USING EXTENDABLE POLES. WE RECEIVED A FURTHER REPORT ON (B)(6) IN WHICH THE HOSPITAL INFORMED US THAT THEY WERE NO LONGER EXPERIENCING CHAMBER FAILURES AS A RESULT OF THE INTRODUCED MEASURES. WE WILL CONTINUE TO WORK WITH (B)(6) TO ENSURE THAT THEY HAVE NO FURTHER PROBLEMS EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER, WHICH FAILS EITHER OF THESE TESTS IS REJECTED. THE CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290 STATE THE FOLLOWING: "USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE [8KPA (~80CMH2O)] MAY LEAD TO CRACKING, WATER LEAKAGE AND, ON RARE OCCASIONS COULD LEAD TO A LOSS OF VENTILATION PRESSURE". "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSION BEFORE CONNECTING TO A PATIENT".

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THE DOME SEPARATING FROM THE BASE AND WATER LEAKAGE FROM AN MR290 AUTOFEED CHAMBER DURING CPAP THERAPY ON A SIPAP MACHINE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 111117

    Patients

    Seq Age Sex Outcome Treatment
    1