BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2950270 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03256
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE A CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET IN WHICH THE SET WAS CAUSING AN DOWNSTREAM OCCLUSION ALARMS. ACCORDING TO THE REPORT, THE FACILITY RECENTLY CONVERTED FROM HOSPIRA CALIBRATED SIGMA INFUSION PUMPS TO BAXTER CALIBRATED SIGMA INFUSION PUMPS. THE FACILITY HAS EXPERIENCED A SUBSTANTIAL INCREASE IN DOWNSTREAM OCCLUSION ALARMS SINCE THE CHANGE. THE REPORTED INDICATED THAT BAXTER WILL BE PERFORMING AN IN-SERVICE TO HELP WITH THIS ISSUE. THE ALLEGED DEFECT OCCURRED DURING PATIENT USE. THERE WERE NO REPORTS OF PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54936 ACCESS ADMINISTRATION, SET, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1