BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2071249 · Received April 27, 2011

    Report

    Report Number
    6000001-2011-03244
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    BRZ
    PMA / PMN Number
    K993120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE (CPS) THAT THEY HAD TO CHANGE THE INTERLINK Y-TYPE BLOOD SOLUTION SET, PRODUCT CODE 2C6723, LOT NUMBER UNKNOWN, DUE TO THE FILTER CLOGGING WHEN PERFORMING A MASS TRANSFUSION OF BLOOD. THEY ADD A 40 MICRON PALL FILTER ON TOP OF THE SET AT THIS FACILITY. THE CUSTOMER DOES NOT THINK THIS SET IS APPROPRIATE FOR USE WITH MASS TRANSFUSIONS AND IS NOT CURRENTLY USING THE PRODUCT ANYMORE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 40 MICRON PALL FILTER