BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK PACLITAXEL SET

    MDR report key: 1790106 · Received August 10, 2010

    Report

    Report Number
    6000001-2010-02442
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    May 5, 2010
    Report Date
    May 6, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K981792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT RETURNED FOR EVALUATION, HOWEVER, A BATCH REVIEW WAS COMPLETED FOR THE REPORTED LOT AND WAS WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STATUS OF A SAMPLE IS PENDING A RESPONSE FROM THE CUSTOMER. THIS WAS ORIGINALLY REPORTED UNDER 6000001-2010-00834. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. THERE WERE NO PRODUCT PERFORMANCE ALLEGATIONS OR ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER TECHNICAL SUPPORT OF A CUT IN THE TUBING OF THE INTERLINK PACLITAXEL SET. A FLO-GARD PUMP WAS BEING USED. THE CUT SEEMS TO BE AT THE LOCATION OF THE BLUE SLIDE CLAMP. IT WAS USED WITH CHEMOTHERAPY DRUGS; THEREFORE, THE DEFECTIVE TUBING WAS DISCARDED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO OTHER INFORMATION WAS AVAILABLE. THIS IS REPORT 4 OF 4 RECEIVED WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK PACLITAXEL SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R10C04012

    Patients

    Seq Age Sex Outcome Treatment
    1