BEUDAMED
    FDA Adverse Event Other Summary report: N

    SERVO-I

    MDR report key: 3150069 · Received June 3, 2013

    Report

    Report Number
    8010042-2013-00090
    Event Type
    Other
    Date Received
    June 3, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BROKEN-OFF PIECE OF THE EDI CATHETER STILL REMAINS IN THE PT. X-RAYS TAKEN SHOW THAT THE PIECE REMAINS IN THE SAME PLACE AND HAS NOT MOVED. THE PT IS BEING FED INTRAVENOUSLY SO THE STOMACH AND BOWEL ARE NOT VERY ACTIVE WHICH ACCORDING TO THE HOSPITAL MIGHT EXPLAIN WHY THE PIECE IS STATIC. NO MEASURES HAVE SO FAR BEEN TAKEN TO REMOVE THE BROKEN-OFF PIECE. ANOTHER EDI CATHETER WAS INSERTED TO CONTINUE PT TREATMENT. IT IS IN PLACE AND FUNCTIONING PROPERLY. THE REMOVED EDI CATHETER IS SEQUESTERED BY THE HOSPITAL AND IT HAS NOT BEEN SENT BACK FOR INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED AFTER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242758 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other