BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2073367 · Received May 1, 2011

    Report

    Report Number
    6000001-2011-03319
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. 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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A BURETROL SET IN WHICH THE ROLLER CLAMP WAS NOT FUNCTIONAL SINCE IT DID NOT REGULATE SOLUTION. THIS REPORTED CONDITION OCCURRED DURING SETUP. 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 - CALI SE11AE7

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION