BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD NV PRIMARY PIGGYBACK SET

    MDR report key: 1023680 · Received April 1, 2008

    Report

    Report Number
    9613251-2008-00076
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 14, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K971293
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICES WERE DISCARDED. ALL AFFECTED CUSTOMERS WERE NOTIFIED VIA A DEVICE INFO LETTER DATED SEPTEMBER 20, 2007. SEE ATTACHED LETTER.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF DIFFICULTY REGULATING FLOW; SUBSEQUENTLY THE PTS RECEIVED MORE IV FLUIDS THAN INTENDED. THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED AMOUNTS OF 5% DEXTROSE AND LACTATED RINGER'S SOLUTION. THE NURSES USED THE CAIR CLAMP TO REGULATE THE FLOW RATES. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, IT WAS REPORTED THE FLOW RATES ARE "MUCH FASTER THEN THEY THOUGHT BECAUSE THE ENTIRE BAG EMPTIES FASTER THAN IT SHOULD." THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD NV PRIMARY PIGGYBACK SET 80-FPA FPA HOSPIRA LTD. NA 541154W

    Patients

    Seq Age Sex Outcome Treatment
    1 PEDS