BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOLINK IV ACCESS DEVICE W/POSITIVE FLUID DISPLACEMENT

    MDR report key: 1897007 · Received November 11, 2010

    Report

    Report Number
    6000001-2010-04811
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    June 29, 2010
    Report Date
    October 13, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K042936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN, THEREFORE A BATCH REVIEW CANNOT BE PERFORMED.

    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. 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 THAT A FLOLINK LUER ACTIVATED DEVICE BECAME DISCONNECTED FROM A BBRAUN ULTRASITE IV ADMIN SET. THE CONDITION OCCURRED ON (B)(6) 2010 AND THE CHEMOTHERAPY MEDICATION BEING INFUSED WAS HERCEPTIN. THE INFUSION WAS NOT ABLE TO BE COMPLETED. THE SEPARATION OCCURRED ABOUT HALF WAY THROUGH THE INFUSION. THE PATIENT AND THE NURSE WERE EXPOSED WHEN THE CHEMO LEAKED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS IN REGARDS TO THE PATIENT EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOLINK IV ACCESS DEVICE W/POSITIVE FLUID DISPLACEMENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1