BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, ELASTOMERIC

    MDR report key: 2001430 · Received February 25, 2011

    Report

    Report Number
    6000001-2011-01341
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: DEVICE WAS NOT RECEIVED AT BAXTER FOR EVALUATION; THEREFORE, THE BROKEN CONDITION WAS NOT CONFIRMED. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. NO OTHER OBSERVATION WAS FOUND ON THE UNITS. 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: PER THE CUSTOMER, THE SAMPLE(S) WILL NOT BE RETURNED TO BAXTER FOR EVALUATION AS THEY HAVE BEEN DISCARDED. THEREFORE, THE REPORTED CONDITION OF "BROKEN TUBING' COULD NOT BE CONFIRMED. IN ADDITION, THE CUSTOMER COULD NOT SUPPLY BAXTER WITH THE LOT NUMBER; THEREFORE, A BATCH REVIEW COULD NOT BE CONDUCTED. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER HEALTHCARE THAT AN UNKNOWN QUANTITY OF CE INTERMATE SV200 DEVICES WERE OBSERVED WITH BROKEN TUBING. ACCORDING TO THE CUSTOMER, "UNDER THE VALVE THERE IS A CLEAN BREAK WITH THE PLASTIC TUBING." THERE IS NO PATIENT INVOLVEMENT AS THESE HAVE BEEN OBSERVED BEFORE USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1