BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLM W/MODIFD B

    MDR report key: 2181043 · Received July 7, 2011

    Report

    Report Number
    9615050-2011-00482
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    January 10, 2011
    Report Date
    June 9, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 THE DEVICE DELIVERED LESS IV FLUID THAN INTENDED. THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED IV SOLUTION. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE NOTED THAT THE DEVICE HAD DELIVERED LESS IV FLUID THAN INTENDED; HOWEVER, NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OR THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XLM W/MODIFD B 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK