BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2160369 · Received July 13, 2011

    Report

    Report Number
    6000001-2011-11678
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 16, 2011
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THREE (3) INTERLINK PACLITAXEL SETS THAT WERE DISCONNECTED FROM AN AVIVA BAG. AN ACTUAL SAMPLE WAS RECEIVED AND NOT CONFIRMED FOR THE ISSUE. THE SAMPLE WAS RECEIVED SECURELY ATTACHED TO THE SOLUTION PORT OF A BAG WITHOUT AID OF TAPE OR ANY OTHER SUPPORT. THE SPIKE WAS REMOVED AND THE SHAFT WAS VISUALLY INSPECTED, DIMENSIONALLY INSPECTED, AND FOUND TO MEET SPECIFICATIONS. THE OTHER TWO (2) ACTUAL SAMPLES WERE NOT SENT IN FOR AN EVALUATION. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED. BATCH RECORDS WERE REVIEWED AND NO DEVIATION WAS FOUND. AS THE PROBLEM COULD NOT BE CONFIRMED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).IT IS UNKNOWN IF THE SAMPLE IS AVAILABLE FOR EVALUATION. HOWEVER, IF THE CUSTOMER DECIDES TO SEND IN THE SAMPLE, A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN PERFORMED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. THE PRODUCT CODE OF THIS DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, IT DOES NOT HAVE A US 510K NUMBER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER PRODUCT SURVEILLANCE OF INTERLINK VENTED PACLITAXEL SETS THAT THEY ARE USING WITH AVIVA BAGS THAT WERE DISCONNECTING FROM THE BAGS DURING AN UNKNOWN PROCESS STEP. THEY USE AVIVA 5% DEXTROSE BAGS THAT ARE 250ML AND 500ML WITH THESE SETS. THIS CONDITION OCCURRED 3 TIMES IN WHICH THE SETS CAME OUT OF THE PORT ON THE BAG AND CHEMOTHERAPY WAS SPILLING ALL OVER THE FLOOR. THE CUSTOMER IS NOW TAPING THE SET TO THE BAG. THERE WAS NO PATIENT INVOLVEMENT OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA UNKNOWN MANUFACTURING FACILITY R11F24046

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN CHEMOTHERAPY DRUG, AVIVA BAG