BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2601075 · Received June 6, 2012

    Report

    Report Number
    6000001-2012-11408
    Event Type
    Malfunction
    Date Received
    June 6, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 22, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K964850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE A 0.22 MICRON EXTENSION SET IN WHICH THE FILTER CHAMBER WAS EMPTYING AND BOLUSING INTO THE PATIENT. THE EXTENSION SET WAS IN USE WITH AN UNKNOWN ALARIS PRIMARY SET AND A CAREFUSION PUMP. THE FACILITY CLARIFIED THAT THEY DO NOT BELIEVE THAT THE THERE WAS A SPECIFIC PROBLEM WITH THE BAXTER SET OR THE ALARIS SET. THE FACILITY BELIEVES THAT IT WAS AN INCOMPATIBILITY BETWEEN THE TWO SETS. THIS OCCURED WITH A CAREFUSION (ALARIS) PUMP. THE FACILITY CLARIFIED THAT THEY STRONGLY BELIEVE THIS IS A COMPATABILITY ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ALARIS (CAREFUSION) INFUSION PUMP| UNKNOWN ALARIS PRIMARY SET