BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM PE LINED LT RESIST 272CM NDEHP

    MDR report key: 3349600 · Received August 26, 2013

    Report

    Report Number
    9615050-2013-02535
    Event Type
    Malfunction
    Date Received
    August 26, 2013
    Date of Event
    July 18, 2013
    Report Date
    July 23, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF (B)(4) AND HAS A 510K OF K982159. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY IN CRITICAL THERAPY DURING DIFFICULTY TO PRIME THE TUBING SET. THE TUBING WAS TO BE USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF NORADRENALIN AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT DURING PRIMING OF THE TUBING SET, AN UNSPECIFIED VOLUME OF AIR WAS NOTED IN THE CASSETTE OF THE TUBING SET. THE CUSTOMER CONTACT REPORTED THAT THE AIR COULD NOT BE REMOVED AND THE TUBING SET COULD NOT BE PRIMED. THE SOLUTION CONTAINER AND THE TUBING SET WERE REPLACED AND THE THERAPY WAS INITIATED. THE CUSTOMER CONTACT REPORTED AN UNSPECIFIED DELAY IN CRITICAL THERAPY; HOWEVER, THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416223 PLUM PE LINED LT RESIST 272CM NDEHP UNK FPA HOSPIRA COSTA RICA LTD. NA 171565H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK