BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2082322 · Received May 9, 2011

    Report

    Report Number
    6000001-2011-03808
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION - CARTAGO
    Product Code
    FPA
    PMA / PMN Number
    K981792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. THE DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, IT DOES NOT CONTAIN A U.S. 510K NUMBER. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF AN INTERLINK SET THAT WAS LEAKING AT THE FILTER. AIR WAS BEING DRAWN INTO THE LINE. HOSPITAL STAFF HAS REPORTED THAT THIS MAY BE DUE TO ANOTHER PRODUCT INVOLVED. THIS CONDITION 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 CORPORATION - CARTAGO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION