BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK PACLITAXEL SET

    MDR report key: 1790112 · Received August 10, 2010

    Report

    Report Number
    6000001-2010-02443
    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). 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.

    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.

    Description of Event or Problem · 1

    PT DIAGNOSIS: MASSIVE TEAR OF RIGHT ROTATOR CUFF, THIS WAS SURGICALLY REPAIRED ON (B)(6) 2010 USING TEI BIOSCIENCES INC. TISSUE MEND. TEN DAYS AFTER SURGERY, PT WAS NOTED TO HAVE BULGE AND SOME REDNESS. THE PT WAS PLACED ON ANTIBIOTICS WITH NO RESOLVE. ON (B)(6) 2010, THE PT WAS RETURNED TO SURGERY FOR I & D OF WOUND. DURING SURGERY, IT WAS NOTED THAT THE TISSUE MEND HAD TOTALLY DISINTEGRATED AND THE BACTERIA CULTURED FROM THE WOUND WAS VERY UNUSUAL. IT IS TSUKAMURELLA SP. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: TO REPAIR ROTATOR CUFF TEAR.

    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 3 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