BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARCADIA MEDICAL CUFFLESS TRACHEOSTOMY TUBE

    MDR report key: 2444212 · Received February 6, 2012

    Report

    Report Number
    3004590970-2012-00002
    Event Type
    Death
    Date Received
    February 6, 2012
    Date of Event
    January 15, 2012
    Report Date
    January 18, 2012
    Manufacturer
    ARCADIA MEDICAL
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOGRAPH OF DEVICE WAS PROVIDED. A PHYSICAL INSPECTION OF THE DEVICE HAS NOT YET OCCURRED, BUT THE REPORT AND PHOTOGRAPH REVEAL THE ROOT CAUSE OF THE EYELET FAILURE. THE SILICONE EYELET TORE, ENABLING THE TRACH TUBE TO BECOME DISLODGED. IT WAS REPORTED THAT NECK TIES CONTAINING VELCRO WERE USED (KAPITEX TRACHI MINI HOLD), RATHER THAN THE COTTON TWILL NECK TIES PROVIDED WITH THE PRODUCT. USE OF VELCRO NECK TIES AND USE OF SHARP OBJECTS IS WARNED AGAINST IN THE MANUFACTURER INSTRUCTIONS FOR USE. DO NOT USE ANY METAL OR PLASTIC HOOKS OR OBJECTS WITH SHARP EDGES IN THE REINFORCED EYES OF THE NECK FLANGE AS THIS MAY TEAR THE SOFT SILICONE MATERIAL RESULTING IN SPLITTING OF THE EYES. A TUBE WITH TORN NECK FLANGE EYES MAY BECOME COMPLETELY DISLODGED RESULTING IN RESPIRATORY FAILURE OR DEATH. USE THE TWILL TAPE SUPPLIED WITH TUBE AND TIE THROUGH THE NECK FLANGE EYES TO SECURE THE TUBE TO THE PATIENT'S NECK. DO NOT USE A TUBE THAT IS TORN OR DAMAGED IN ANY WAY. USE CAUTION WITH VELCRO AND FOAM NECK STRAPS. SOME PATIENTS MAY PULL THE VELCRO STRAP OPEN ALLOWING THE TUBE TO RELEASE AND COMPLETELY DISLODGE, RESULTING IN RESPIRATORY FAILURE OR DEATH. THIS DEVICE MUST BE THROUGHLY INSPECTED PRIOR TO EACH USE. NOTE THE CONDITION OF THE CONNECTOR, THE BODY OF THE TUBE, THE CUFF, THE INFLATION LINE, THE NECK FLANGE AND FLANGE EYES PRIOR TO EACH INSERTION. DO NOT USE A TUBE THAT IS CUT OR DAMAGED IN ANY WAY. USE OF A DAMAGED TUBE CAN RESULT IN AIRWAY COMPROMISE. THE REPORTER INDICATED THAT THE NECK TIES WERE CHANGED DAILY, WHICH SUGGESTS CONTACT BETWEEN A SHARP OBJECT (VELCRO EDGES) AND THE SILICONE MATERIAL DAILY FOR A TOTAL OF 31 DAYS OF USE, WHICH WAS THE REPORTED TIMEFRAME THE TUBE WAS INSERTED INTO THE PATIENT. THE PRODUCT IS INDICATED FOR USE AS FOLLOWS: THIS TUBE IS INTENDED TO PROVIDE DIRECT TRACHEAL ACCESS FOR A TRACHEOTOMIZED PATIENT FOR UP TO 29 DAYS. IT MAY BE REPROCESSED UP TO 5 TIMES FOR SINGLE PATIENT REUSE. ARCADIA MEDICAL DOES NOT MANUFACTURE OR SUPPLY VELCRO NECK TIES WITH ITS PRODUCT. THE PRODUCT WAS NOT USED IN ACCORDANCE WITH INSTRUCTIONS FOR USE. (B)(4).

    Description of Event or Problem · 1

    A PEDIATRIC PT WAS CANNULATED WITH A 4.0 MM ID ARCADIA MEDICAL TRACHEOSTOMY TUBE ON (B)(6) 2011. ON (B)(6) 2012, THE TRACHEOSTOMY TUBE DISLODGED AT HOME AND THE CHILD SUFFERED A CARDIOPULMONARY ARREST. THE PARENTS COMMENCED CPR. THE CHILD WAS RETRIEVED FROM THE LOCAL HOSP TO (B)(6) CHILDREN'S HOSP IN (B)(6). ON CLOSER INSPECTION OF THE DEVICE BY MEDICAL PHYSICS, THE STANDARD V-NECK FLANGE WAS RIPPED AT ONE OF THE ENDS USED FOR SECURING THE NECK STRAP. THE PT'S PARENTS WERE ASKED TO USE A DIFFERENT NECK STRAP THAN THE TWILL TAPE SUPPLIED BY ARCADIA MEDICAL WITH THE TRACHEOSTOMY TUBE (MANUFACTURED BY KAPITEX HEALTHCARE LTD (B)(4), TRACHI-HOLD MINI). ON (B)(6) 2012, THE PT WAS REPORTED TO HAVE DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCADIA MEDICAL CUFFLESS TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO ARCADIA MEDICAL AMFNF-49 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Death