BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP 3CLV YSTE MACR

    MDR report key: 2051007 · Received April 4, 2011

    Report

    Report Number
    9613251-2011-00049
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 7, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF LACTATED RINGER'S SOLUTION VIA GRAVITY FLOW. THE PT WAS REPORTED TO BE LYING ON A SURGICAL TRANSPORT CART IN THE PREOPERATIVE AREA. THE NURSE REPORTED THAT AFTER THE BED RAIL OF THE CART WAS RAISED, THE TUBING SET WAS "LIGHTLY PULLED AGAINST" THE CART AND THE TUBING SEPARATED FROM THE MIDDLE CLAVE Y-SITE. IT WAS REPORTED THAT APPROX 3ML OF BLOOD BACK WAS NOTED IN THE TUBING. THE NURSE CLAMPED THE TUBING WITH THE SLIDE CLAMP. THE TUBING SET WAS REPLACED AND THE THERAPY EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP 3CLV YSTE MACR 80FPA FPA HOSPIRA LTD. NA 963194W

    Patients

    Seq Age Sex Outcome Treatment
    1