BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L.C. 5000/CE NITROGLYCERIN PUM

    MDR report key: 2480628 · Received February 22, 2012

    Report

    Report Number
    9615050-2012-00148
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 26, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER 1878. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K810317. THE INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK; SUBSEQUENTLY BLOOD LOSS WAS NOTED. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT VIA A PLUM PUMP. IT WAS REPORTED THAT AFTER THE DELIVERY OF THE CHEMOTHERAPY AGENT WAS COMPLETE, THE NURSE CLAMPED THE TUBING USING THE SLIDE CLAMP THAT WAS DISTAL TO THE CASSETTE AND REMOVED THE TUBING SET FROM THE PUMP TO ¿WASH IT¿. IT WAS REPORTED THAT AFTER THE TUBING SET WAS LOADED BACK INTO THE PUMP, THE NURSE NOTED 50ML OF BLOOD LOSS ON THE FLOOR. IT WAS REPORTED THAT A CUT IN THE TUBING WAS NOTED AT AN UNSPECIFIED LOCATION BETWEEN THE CASSETTE AND THE DISTAL END OF THE TUBING SET. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO DELAYS IN THERAPY CRITICAL FOR THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L.C. 5000/CE NITROGLYCERIN PUM UNK FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK