BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE 5000 PUMPSET/CE/GAMMA (50/CAS)

    MDR report key: 3281776 · Received August 8, 2013

    Report

    Report Number
    9615050-2013-02311
    Event Type
    Malfunction
    Date Received
    August 8, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 10, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER 01642. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN 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 LEAK. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF SALINE. IT WAS REPORTED THAT DURING PRIMING PRIOR TO PATIENT USE, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED BETWEEN THE DRIP CHAMBER AND THE TUBING CONNECTION OF THE TUBING SET. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375049 LIFECARE 5000 PUMPSET/CE/GAMMA (50/CAS) UNK FRN HOSPIRA COSTA RICA LTD. NA 190525H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA