BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASK TRACH ADULT DISP 50/CS

    MDR report key: 2974715 · Received February 22, 2013

    Report

    Report Number
    2050001-2013-00004
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BYG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE LOT NUMBERS ARE UNKNOWN, TWO MASKS WERE RETURNED BY THE CUSTOMER FOR EVALUATION. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE TRACH MASKS WERE USED TO DELIVER OXYGEN TO A PATIENT USING AN RT210 CIRCUIT. THE RT210 CIRCUIT IS MANUFACTURED BY FISHER & PAYKEL. THE RT210 CIRCUIT HAS A CONICAL CONNECTOR THAT WAS ATTACHED TO THE AIRLIFE TRACH MASK. THE CONNECTOR ON THE TRACH MASK DOES NOT HAVE THE APPROPRIATE DESIGN TO BE FITTED WITH A CONICAL CONNECTOR. AS A RESULT, IT CAN EASILY DISCONNECT. THE CURRENT INSTRUCTIONS ON THE TRACH MASK LABEL RECOMMEND USING 22MM I.D. TUBING FOR AEROSOL DELIVERY. HOWEVER, FOR OXYGEN DELIVERY THE LABEL STATES TO CONNECT AN OXYGEN CONNECTOR TO THE MASK. IT WAS CONFIRMED THAT CAREFUSION DOES NOT MANUFACTURE AN OXYGEN CONNECTOR THAT IS COMPATIBLE WITH THE TRACH MASK. THE LABEL WILL BE UPDATED TO REMOVE THE REFERENCE TO ¿OXYGEN CONNECTOR¿ AND APPROPRIATE INSTRUCTIONS WILL BE ADDED FOR OXYGEN DELIVERY. THE LABEL WILL BE UPDATED FOR BOTH ADULT (001225) AND PEDIATRIC (001226) TRACH MASKS. A CHANGE CONTROL REQUESTS HAS BEEN INITIATED BY CAREFUSION TO MAKE THIS CHANGE. IN ADDITION, THE DIMENSIONS OF THE CONNECTOR ON THE TWO RETURNED AIRLIFE TRACH MASKS WERE FOUND TO BE SLIGHTLY OUT OF SPECIFICATION BY APPROXIMATELY .020". A SCAR WAS OPENED (FG-13-05) AGAINST THE SUPPLIER THAT MANUFACTURES THE TRACH MASK FOR CAREFUSION. SINCE THE EXACT LOT NUMBERS OF THE RETURNED TRACH MASKS ARE UNKNOWN, THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR THREE OLDER LOTS OF TRACH MASKS (001225). THERE WERE NO NON-CONFORMANCES IDENTIFIED WITH THESE THREE LOTS THAT WERE REVIEW. AS A PART OF CONTINUOUS IMPROVEMENT, THE NEW MOLD FOR MANUFACTURING THE TRACH MASK CONNECTOR HAS BEEN VALIDATED. MOVING FORWARD, ALL THE DEVICES WILL BE ASSEMBLED USING PARTS FROM THIS NEW MOLD, WHICH WILL OCCUR FOR BOTH THE ADULT AND PEDIATRIC TRACH MASKS.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE CUSTOMER: 'WE HAVE EXPERIENCED SOME PROBLEMS WITH THE CONNECTION BETWEEN THE AIRLIFE TRACH COLLAR AND THE INSPIRATORY LIMB OF THE FISHER AND PAYKEL VENT CIRCUIT.  THE CONNECTION HAS BEEN SO LOOSE THAT THE TUBING HAS SPONTANEOUSLY JUST SLIPPED OFF ON ITS OWN AND HAS CAUSED SOME PATIENTS TO DESATURATE.  WE HAVE REPLACED THE TRACH COLLARS AND THE CONNECTION SEEMS MUCH TIGHTER WITH THE NEW TRACH COLLARS.' A REQUEST WAS MADE FOR ADDITIONAL INFORMATION SUCH AS PART NUMBER, LOT NUMBERS, QUANTITY AFFECTED, IF A SAMPLE WAS AVAILABLE, AND IF ANY PATIENT INJURY OCCURRED.  'THERE WERE ONLY TWO PATIENTS THAT WERE CALLED TO MY ATTENTION. ONE PATIENT DID DESATURATE ON THE PULSE O2 INTO THE 80% RANGE WHICH IS WHAT ALERTED STAFF TO THE ISSUE.  NO LOT INFORMATION IS AVAILABLE.  I WAS GOING TO SAVE THE TRACH COLLAR BUT IT WAS HEAVILY SOILED WITH MUCOUS AND THOUGHT IT WAS BEST TO DISCARD IT.  I HAVE NOT HEARD OF ANY FURTHER ISSUES WITH THE TRACH COLLARS SINCE THEN.  ADDITIONAL INFORMATION WAS OBTAINED FROM THE CUSTOMER ON (B)(6) 2013.  CUSTOMER (B)(6), REPORTED THAT THE TRACH COLLAR WAS USED IN CONJUNCTION WITH A FISHER AND PAYKEL INSPIRATORY LIMB TO ATTACH TO THE HEATER. HE STATED THAT THIS IS THE FACILITY'S METHOD OF A WEANING PARAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78483 MASK TRACH ADULT DISP 50/CS MASK, OXYGEN BYG CAREFUSION 001225-A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1