BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM MONITORING KIT

    MDR report key: 530893 · Received March 4, 2004

    Report

    Report Number
    1713468-2004-00008
    Event Type
    Malfunction
    Date Received
    March 4, 2004
    Date of Event
    February 11, 2004
    Report Date
    February 11, 2004
    Manufacturer
    ABBOTT LABS
    Product Code
    DRS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT REC'D OF A TUBING BREAK DISTAL TO THE TRANSDUCER. IT WAS REPORTED THAT THE TRANSDUCER KIT, WHICH WAS POLE MOUNTED, WAS CONNECTED TO THE PT'S ARTERIAL LINE WHEN THE TUBING "BROKE" IN AN UNSPECIFIED AREA BETWEEN THE TWO STOPCOCKS. A NURSE WAS PRESENT AT THE PT'S BEDSIDE WHEN THIS OCCURRED; THEREFORE, THE NURSE TURNED THE STOPCOCK TOWARDS THE PT TO PREVENT BLEED BACK AND BLOOD LOSS. IT WAS REPORTED THAT THE TRANSDUCER KIT WAS REMOVED AND REPLACED WITH ANOTHER ONE THAT WORKED "FINE". THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO FURTHER INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM MONITORING KIT PRESSURE MONITORING KIT DRS ABBOTT LABS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other