BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2103598 · Received May 26, 2011

    Report

    Report Number
    6000001-2011-04726
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    March 29, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - SHERBROOKE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PW, CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, 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). THE CUSTOMER RETURNED 95 UNUSED COMPANION SAMPLES FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. THEREFORE, NO ASSIGNABLE ROOT CAUSE COULD BE DETERMINED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER (B)(4) REGARDING THE INTERLINK CONTINU-FLO SET IN WHICH THE PRODUCT CAME BACK UP FROM THE SECONDARY BAG TO THE PRIMARY BAG. THE INCIDENT OCCURRED DURING PATIENT 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 ST11C009

    Patients

    Seq Age Sex Outcome Treatment
    1 PRIMARY SET AND BAG