BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3290513 · Received August 15, 2013

    Report

    Report Number
    9611451-2013-00596
    Event Type
    Malfunction
    Date Received
    August 15, 2013
    Report Date
    July 17, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: MANUFACTURING DATE: QUANTITY AFFECTED: 120510, 05/10/2012, 3; 120724, 07/24/2012, 1; 121023, 10/23/2012, 2; 130327, 03/27/2013, 1. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS FROM THE DISTRIBUTOR. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE RECEIVED THE COMPLAINT DEVICES AND HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: 120510 MANUFACTURING DATE: 05/10/2012 QUANTITY AFFECTED: 3; 120724, 07/24/2012, 1; 121023, 10/23/2012, 2; 130327, 03/27/2013, 1. METHOD: ONLY THE COMPLAINT MR290V CHAMBERS WITH LOT NUMBERS 120510 AND 121023 WERE RETURNED TO FPH FOR INVESTIGATION. THE RETURNED DEVICES WERE VISUALLY INSPECTED AND CONNECTED TO A WATERBAG TO TEST FOR LEAKS. OUR INVESTIGATION IS ALSO BASED ON OUR PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. RESULTS: ONE OF THE CHAMBERS WITH LOT NUMBER 120510 HAD SPIKE DETACHED FROM THE FEEDSET TUBE. FURTHER INSPECTION REVEALED THAT SUFFICIENT AMOUNT OF GLUE WAS PRESENT AROUND THE SPIKE TUBING CONNECTION. THE GLUE WAS SLIGHTLY STICKY. THE OTHER TWO CHAMBERS, WITH LOT NUMBER 120510 THAT STILL HAD SPIKES ATTACHED TO THE FEEDSET TUBES, WERE CONNECTED TO THE WATER BAG. SMALL DROPS OF WATER BEGAN TO BUILD UP AT THE CONNECTION BETWEEN THE WATER FEEDSET TUBES AND SPIKES. VISUAL INSPECTION REVEALED THAT SUFFICIENT AMOUNT OF GLUE WAS PRESENT AROUND THE SPIKE TUBING CONNECTION; HOWEVER, THE GLUE HAD NOT BONDED. NO FAULT WAS FOUND TO RETURNED CHAMBERS WITH LOT NUMBER 121023. A LOT CHECK REVEALED TWO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120510 AND NONE FOR LOT NUMBER 121023. CONCLUSION: WE WERE UNABLE TO DETERMINE DEFINITIVELY THE ROOT CAUSE OF THE REPORTED FAULT; HOWEVER, IT IS POSSIBLE THAT THE LEAKS FROM THE FEEDSET TUBES WERE DUE TO THE FAILURE OF THE GLUE BOND THAT JOINS THE SPIKES TO THE WATER FEEDSET TUBES. OUR PREVIOUS INVESTIGATION ON SIMILAR COMPLAINTS HAVE ALSO SHOWN THAT SUCH PROBLEM HAS BEEN CAUSED BY THE USER REMOVING THE SPIKE BY GRASPING THE TUBING INSTEAD OF THE SPIKE. WE HAVE CONDUCTED EXTENSIVE TESTING OF THE MR290 CHAMBER, WITH PARTICULAR EMPHASIS ON FEEDSET BREAKS. SIGNIFICANTLY WE HAVE NOT BEEN ABLE TO REPLICATE FAILURE OF THE FEEDSET TUBE AT THE CHAMBER DOME IN ANY OF OUR TESTING. THE SPECIFICATION FOR THE CHAMBER REQUIRES THAT THE FEEDSET TUBE SHOULD HAVE A BREAKING STRAIN OF 30 NEWTONS. DURING PRODUCTION, PULL TESTING OF THE FEEDSET STRENGTH AT BOTH SPIKE AND DOME END IS PERFORMED EVERY HOUR ON MR290 CHAMBERS FROM EACH PRODUCTION LINE. IF ANY FAULTS ARE DETECTED THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. ADDITIONALLY ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. CHAMBERS THAT FAIL ANY OF THESE TESTS ARE DISCARDED. THIS SUGGESTS THAT THE PROBLEM OCCURRED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 AUTOFEED HUMIDIFICATION CHAMBERS STATE THE FOLLOWING: SET APPROPRIATE VENTILATOR ALARM." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WATER LEAKED AT THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND SPIKE OF SEVEN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS. THE DISTRIBUTOR RECEIVED THESE COMPLAINTS FROM FOUR DIFFERENT HOSPITALS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WATER LEAKED AT THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND SPIKE OF SEVEN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS. THE DISTRIBUTOR RECEIVED THESE COMPLAINTS FROM FOUR DIFFERENT HOSPITALS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395397 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1