BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD NV PRIMARY PIGGYBACK SET

    MDR report key: 1032000 · Received April 21, 2008

    Report

    Report Number
    9613251-2008-00092
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 28, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. ALL AFFECTED CUSTOMERS WERE NOTIFIED VIA A DEVICE INFO LETTER DATED OCTOBER 9, 2007.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED INACCURATE DELIVERY. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED AMOUNT OF AN UNSPECIFIED IV SOLUTION. THE CAIR CLAMP WAS BEING USED TO REGULATE THE FLOW. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE CUSTOMER CONTACT REPORTED "THE REGULATOR WOULD STOP THE FLOW OR MAKE IT GO TOO FAST." THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADD'L 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 521014W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK