BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SET-PRIMARY DRUGADMIN. SET

    MDR report key: 1942949 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06445
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    April 22, 2010
    Report Date
    July 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPANION SAMPLE WAS SUBMITTED FOR EVALUATION. A VISUAL EXAMINATION OF THE SAMPLE DID NOT REVEAL ANY ABNORMALITIES. THE SAMPLE WAS SUBMITTED FOR UNDER-WATER PRESSURE TESTING AND FUNCTIONAL TESTING AND THE RESULTS WERE SATISFACTORY. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SINCE THE CONDITION COULD NOT BE CONFIRMED, THE ROOT CAUSE OF THIS CONDITION COULD NOT BE IDENTIFIED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS 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) A CONTINU-FLO DRUG ADMINISTRATION SET THAT WAS INVOLVED IN A NO FLOW. ACCORDING TO THE REPORT, BEFORE ATTEMPTING AN INFUSION IT WAS NOTICED THAT THE "SETS WERE BLOCKED." THE CONDITION WAS NOTED PRIOR TO USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS IS REPORT 1 OF 3 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINU-FLO SET-PRIMARY DRUGADMIN. SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 09E04V366

    Patients

    Seq Age Sex Outcome Treatment
    1