BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2237758 · Received September 8, 2011

    Report

    Report Number
    6000001-2011-23159
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K984381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 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 COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER US ONE (1) NON-DEHP CL BURETROL (BALL VALVE DRIP CHMBR) SET W/2YS 60DPM IN WHICH THERE WAS "AIR IN THE LINE, SO THAT THE BALL CHECK WOULD NOT FUNCTION PROPERLY." THE FACILITY STAFF HAS NOT BEEN ABLE TO REPLICATE THE PROBLEM. THE ISSUE WAS DISCOVERED DURING PATIENT INFUSION, HOWEVER, NO AIR MADE IT TO THE PATIENT. NO MEDICAL INTERVENTION OR INJURY WAS REPORTED. NO SAMPLES ARE AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1