BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP 3CLV YSTE MACR

    MDR report key: 2896697 · Received December 28, 2012

    Report

    Report Number
    9613251-2012-00249
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    October 30, 2012
    Report Date
    December 3, 2012
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012. THE REPORT NUMBER IS 2400010000-2012-08041. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH RECEIVED THAT STATED: ¿THE PRIMARY SET TUBING CONNECTED TO THE DRIP CHAMBER WAS NOT CONNECTED AT THE BACK-CHECK VALVE. THIS SEPARATION OF THE TUBING FROM THE VALVE OCCURRED WHEN THE NURSE WAS SPIKING THE IV BAG. CAUSE IS UNK: NO EXCESSIVE FORCE PLACED ON LINE. NO PATIENT IMPACT. ANOTHER PRIMARY TUBING SET WAS OBTAINED AND SET UP WITHOUT ANY PROBLEMS. EVENT DID NOT REACH THE PATIENT¿. UPON FURTHER QUERY THE FOLLOWING INFO WAS PROVIDED THAT INDICATED A SEPARATION. AT AN UNSPECIFIED TIME, THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION VIA GRAVITY. IT WAS REPORTED THAT WHEN THE NURSE ATTEMPTED TO SPIKE THE IV SOLUTION CONTAINER, THE TUBING SEPARATED FROM THE PROXIMAL END OF THE BACKCHECK VALVE. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. 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 200094W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA