BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2123813 · Received June 14, 2011

    Report

    Report Number
    6000001-2011-07689
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, AND THE REPORTED CONDITION WAS NOT CONFIRMED. THE SAMPLE WAS TESTED UNDER WATER FOR LEAKAGE AND BLOCKAGE AT 0.56 BAR OF AIR PRESSURE, THIS EVALUATION DOES NOT CONFIRM ANY FUNCTIONALITY ISSUE (NO LEAKAGE OR BLOCKAGE WAS OBSERVED FOR THE THREE SAMPLES TESTED). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN 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. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A CONTROL-A-FLO EXTENSION SET IN WHICH THE TUBING WAS LEAKING DURING FILLING. AFTER CHECKING THE TUBING, THE NURSE NOTED THERE WAS A CRACK ON THE TUBING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10G11V011M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION