BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2173476 · Received July 23, 2011

    Report

    Report Number
    6000001-2011-13562
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BAXTER HEALTHCARE - SHERBROOKE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SENT IN FOR AN EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED WITH SATISFACTORY RESULTS. THE SET WAS PRIMED WITH WATER WITH NO DEFECTS. THE CAUSE OF THIS CONDITION COULD NOT BE IDENTIFIED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THIS DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) REGARDING THE INTERLINK BASIC VENTED SET, IN WHICH THE DRIP CHAMBER COLLAPSED AND IT WAS IMPOSSIBLE TO PRIME THE SET. THEY WERE ATTEMPTING TO PRIME A VIAL OF ALBUMIN. THE CUSTOMER CLOSED AND OPENED THE REGULATING CLAMP MANY TIMES. THE PROBLEM OCCURRED DURING USE, HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ALBUMIN VIAL