BEUDAMED
    FDA Adverse Event Death Summary report: N

    MR290HFV AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1463007 · Received August 28, 2009

    Report

    Report Number
    9611451-2009-00466
    Event Type
    Death
    Date Received
    August 28, 2009
    Report Date
    July 30, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL FOUR (4) COMPLAINT CHAMBERS WERE REPORTED TO BE OF THE SAME LOT, 080410. THE HOSP HAD DISCARDED THE FOUR (4) MR290HFV AUTOFEED HUMIDIFICATION CHAMBERS. CONSEQUENTLY, FISHER & PAYKEL HEALTHCARE WAS UNABLE TO EVALUATE THE CHAMBERS. FISHER & PAYKEL HEALTHCARE RAISED AN INQUIRY WITH THE HOSP IN ORDER TO GAIN FURTHER INFO REGARDING THE ALLEGED EVENT. AN ANALYSIS WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND FURTHER INFO PROVIDED BY THE HOSP, AS WELL AS ANALYSES OF OTHER REPORTED EVENTS RELATING TO LEAKS OR CRACKS OF MR290HFV CHAMBERS. RESULTS: IT WAS REPORTED BY THE HOSP THAT THE CHAMBERS ALLEGEDLY CRACKED "AROUND THE SEAM BETWEEN [THE ALUMINIUM BASE AND DOME" AND LEAKED, HOWEVER, WITHOUT THE COMPLAINT DEVICES, FISHER & PAYKEL HEALTHCARE IS UNABLE TO VERIFY THE PRESENT AND/OR LOCATION OF THE ALLEGED CRACKS. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR MR290 CHAMBERS WITH LOT NUMBER 080410. CONCLUSION: BASED ON THE SETTINGS PROVIDED BY THE HOSP, THE PEAK PRESSURE INSIDE THE CHAMBER DOME AT THE TIME OF THE USE WAS IN EXCESS OF THE MAXIMUM OPERATING PRESSURE. THE MAXIMUM OPERATING PRESSURE OF THE MR290 CHAMBER, AS INDICATED ON THE USER INSTRUCTIONS, IS 8 KPA (APPROXIMATELY 81.8 CM H2O). THE USE OF THE CHAMBER AT A PRESSURE HIGHER THAN THE RECOMMENDED MAXIMUM PRESSURE IS LIKELY TO HAVE CAUSED THE REPORTED EVENT. BASED ON OUR ANALYSIS OF OTHER REPORTED EVENTS RELATING TO LEAKS OR CRACKS OF MR290-HFV CHAMBERS, IT IS POSSIBLE THAT THE ALLEGED CHAMBER LEAKS AND CRACKS MAY BE RELATED TO OSCILLATORY STRESSES INDUCED ON THE MR290HFV CHAMBERS BY A SENSORMEDICS 3100B VENTILATOR. A RECENT CORRECTIVE ACTION / PREVENTATIVE ACTION ('CAPA') PROJECT ADDRESSED THE ISSUE OF CRACKED MR290HFV CHAMBERS THAT HAD BEEN USED IN CONJUNCTION WITH THE SENSORMEDICS 3100B VENTILATOR. AS A RESULT OF THE CAPA, THE USER INSTRUCTIONS WERE UPDATED TO INCLUDE THE FOLLOWING WARNING: "USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE MAY LEAD TO CRACKING, WATER LEAKAGE AND, ON RARE OCCASIONS, COULD LEAD TO A LOSS OF VENTILATION PRESSURE." OUR MONITORING AND TRENDING OF EVENTS INVOLVING CRACKED MR290HFV CHAMBERS USED IN CONJUNCTION WITH THE SENSORMEDICS 3100B VENTILATOR HAS A RATE OF OCCURRENCE IN THE LAST YEAR. WE ARE NOT AWARE OF ANY OTHER REPORTED EVENTS RELATING TO LEAKS OR CRACKS OF MR290HFV CHAMBERS WHERE THE PRODUCT WAS USED WITHIN THE SPECS INDICATED ON THE USER INSTRUCTIONS. AS PART OF OUR STRATEGY FOR CONTINUOUS IMPROVEMENT, FISHER & PAYKEL HEALTHCARE IS CLOSELY MONITORING COMPLAINT DATA AND EVALUATING POTENTIAL DESIGN IMPROVEMENT OPTIONS IN ORDER TO FURTHER REDUCE THE INCIDENCE OF CRACKED CHAMBERS IN APPLICATIONS INVOLVING THE SENSORMEDICS 3100B VENTILATOR.

    Description of Event or Problem · 1

    THE CLINICAL EDUCATOR/REGISTERED RESPIRATORY THERAPIST AT A HOSP REPORTED TO A FISHER & PAYKEL HEALTHCARE CLINICAL PRODUCT SPECIALIST ON JULY 30, 2009, THAT THEY HAD PROBLEMS WITH MR290HFV AUTOFEED HUMIDIFICATION CHAMBER LEAKS THAT CAUSED "SERIOUS DECOMPENSATIONS". IT WAS REPORTED THAT THE CHAMBERS WERE "CRACKING AROUND THE SEAM BETWEEN [THE] ALUMINIUM BASE AND DOME." IT WAS ALSO INDICATED THAT THE PT, WHO WAS SET UP ON THE VENTILATOR WITH THE MR290HFV CHAMBER, WAS CRITICALLY ILL. FISHER & PAYKEL HEALTHCARE SOUGHT FURTHER INFO FROM THE HOSP REGARDING THE REPORTED EVENT AND REC'D THE FOLLOWING INFO: ACCORDING TO THE HOSP, THE FOUR (4) MR290HFV CHAMBERS HAD BEEN USED ON ONE PT WHO WAS SET-UP ON A SENSORMEDICS 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR THAT WAS SET TO A FREQUENCY OF 3 HZ, AMPLITUDE OF 95 AND A MEAN PRESSURE OF 38 CM H2O (NOTE: THE MAXIMUM OPERATING PRESSURE IS 8 KPA, AS INDICATED IN THE MR290 USER INSTRUCTIONS). THE ALLEGED CHAMBER LEAKS AND CRACKS WERE OBSERVED OVER A PERIOD OF THREE (3) WEEKS. THE HOSP REPORTED THAT "THE LEAKS CAUSED [THE] MEAN AIRWAY PRESSURE [TO] DRIFT DOWNWARD WHICH REQUIRED AN INCREASE IN MEAN SETTINGS AS WELL AS AN INCREASE IN FIO2 TO MAINTAIN SATURATIONS" AND "MADE IT DIFFICULT TO MANAGE THE PT EFFECTIVELY." THE HOSP REPORTED THAT "CHANGING THE CHAMBER REQUIRED AN INTERRUPTION OF OSCILLATION" WHICH CAUSED O2 SATURATION LEVELS TO DROP MARKEDLY. AT SOME TIME FOLLOWING THE ALLEGED CHAMBER LEAKS, THE PT PASSED AWAY, ALTHOUGH DETAILS AND NOTIFICATION OF THE PT'S PASSING WERE OMITTED FROM THE HOSP'S INITIAL CORRESPONDENCE. FISHER & PAYKEL HEALTHCARE HAS NOT BEEN ABLE TO ASCERTAIN THE ACTUAL CAUSE OR TIMING OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MR290HFV AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290HFV 080410

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death