BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM APL V13.4 ABG

    MDR report key: 1355349 · Received April 2, 2009

    Report

    Report Number
    2921482-2009-00116
    Event Type
    Malfunction
    Date Received
    April 2, 2009
    Date of Event
    March 1, 2009
    Report Date
    March 11, 2009
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DELIVERY TOOK LONGER THAN EXPECTED. LINE A OF THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF "SALINE" AT A RATE OF 30ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 250ML. LINE B WAS PROGRAMMED IN THE CONCURRENT MODE TO DELIVER AN UNSPECIFIED CONCENTRATION OF IGG(IMMUNOGLOBULIN G) AT A RATE OF 120ML/HR, WITH A VTBI OF 60ML AND THE DELIVERIES WERE STARTED. IT WAS REPORTED THAT 45 MINUTES LATER, THE DEVICE ALARMED THAT THE DELIVERY WAS COMPLETE INSTEAD OF THE EXPECTED 30 MINUTES. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM APL V13.4 ABG 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK