BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2761135 · Received September 26, 2012

    Report

    Report Number
    1416980-2012-00802
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 7, 2012
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED DUE TO CHEMOTHERAPY CONTAMINATION. SINCE THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, 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 CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A LIGHT SENSITIVE DRUG SET IN WHICH THE "CHEMO SET WHICH HAS SPLIT IN PHM.(PUMP HEAD MODULE OF THE COLLEAGUE PUMP)." THE EVENT OCCURRED DURING INFUSION OF DACARBAZINE AT A RATE OF 250ML/HR. THE SET DID NOT LEAK DURING PRIMING WITH SALINE. THE LEAK WAS NOTICED THROUGH THE PUMP AFTER 10 MINUTES OF INFUSION. A PIN PRICK HOLE WAS NOTED IN THE PART OF THE SET WHICH WAS LOADED INTO THE PUMP. A PATIENT WAS INVOLVED, BUT THERE IS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION WAS NEEDED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 DACARBAZINE, COLLEAGUE PUMP ((B)(4))