BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECONDARY MEDICATION SET

    MDR report key: 1942931 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06444
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - SHERBROOKE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER SENT IN AN ACTUAL AND A COMPANION SAMPLE FOR EVALUATION. A VISUALIZATION EXAMINATION OF THE SAMPLES REVEALED THE PRESENCE OF IRREGULARITIES ON THE TIP OF MALE LUER LOCK WHICH CONFIRMS THE REPORTED CONDITION. SURFACE IRREGULARITIES HAVE BEEN SHOWN TO RESULT IN A PARTIALLY OR COMPLETELY INACTIVATED LUER ACTIVATED VALVES. IN ORDER TO ADDRESS THE ISSUE, CORRECTIVE ACTIONS WERE PUT IN PLACE IN 2007 BY BAXTER. HOWEVER, THIS PARTICULAR LOT OF PRODUCT WAS MANUFACTURED BEFORE THE TIME CORRECTIVE ACTIONS WERE PUT IN PLACE BY BAXTER. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, AN MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF THREE 3 SECONDARY MEDICATION SETS THAT HAD A SLOWER DRIP RATE THAN USUAL. EACH SET WAS USED IN CONJUNCTION WITH AN IVEC PUMP THAT WAS SET UP BY A NURSE. THE PROCESS STEP IN WHICH THIS REPORTED CONDITION OCCURRED WAS DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECONDARY MEDICATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SHERBROOKE

    Patients

    Seq Age Sex Outcome Treatment
    1 IVEC PUMP, UNKNOWN SECONDARY BAG