BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCONV PN SEC MACRO OL

    MDR report key: 1062353 · Received June 18, 2008

    Report

    Report Number
    9613251-2008-00185
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 28, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICES WERE DISCARDED.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF NO FLOW. THE SECONDARY TUBING SETS WERE CONNECTED TO UNSPECIFIED PRIMARY TUBING SETS AND WERE BEING USED FOR PIGGYBACK DELIVERIES OF UNSPECIFIED MEDICATIONS VIA UNSPECIFIED PUMPS. THE CUSTOMER CONTACT REPORTED THE UNSPECIFIED PIGGYBACK MEDICATIONS DID NOT FLOW AFTER THE SECONDARY TUBING SETS WERE CONNECTED TO THE PRIMARY TUBING SETS. THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. 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 MCONV PN SEC MACRO OL 80-FPA FPA HOSPIRA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED INFUSION PUMPS| MANUFACTURED BY BAXTER INTERNATIONAL INC.| UNSPECIFIED PRIMARY TUBING SETS