BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2161484 · Received July 14, 2011

    Report

    Report Number
    6000001-2011-11820
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, THIS PRODUCT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.ADDITIONAL NARRATIVE:THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF ENTANGLED COILED TUBING WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGNS OF PHYSICAL ABNORMALITY. FIVE TURNS WERE NOTED ON THE COIL TUBING. THE UNIT WAS MANUALLY FILLED WITH 100 ML OF WATER. DURING AND AFTER FILL, NO EVIDENCE OF ENTANGLEMENT WAS NOTED ON THE COIL TUBING. THE DEVICE WAS ALLOWED TO FLOW UNTIL EMPTIED. DURING FLOW, NO EVIDENCE TANGLED COIL TUBING WAS OBSERVED. NO ROOT CAUSE WAS IDENTIFIED. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. ADDITIONAL INFORMATION: PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. 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

    BAXTER (B)(4) RECEIVED A REPORT THAT A COILED TUBE INFUSOR HAD INTERNAL TUBING TANGLED BETWEEN THE VOLUME INDICATOR AND THE HOUSING DURING PATIENT USE. THE DEVICE WAS FILLED WITH A SOLUTION OF 5-FLUOROURACIL AND SALINE. THIS CONDITION INTERRUPTED THERAPY. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. THE SAMPLE IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10J044

    Patients

    Seq Age Sex Outcome Treatment
    1 5-FLUOROURACIL| SALINE