BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV 5, 12 PACK

    MDR report key: 1982838 · Received February 9, 2011

    Report

    Report Number
    6000001-2011-00784
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF "LEAK" COULD NOT BE CONFIRMED. A BATCH REVIEW COULD ALSO NOT BE PERFORMED AS THE CUSTOMER WAS UNABLE TO PROVIDE BAXTER WITH THE DEVICE LOT NUMBER. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: 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

    IT WAS REPORTED TO BAXTER HEALTHCARE THAT FIVE (5) CE INFUSOR LV DEVICES WERE INVOLVED IN SEPARATE LEAKING INCIDENTS. THE CUSTOMER DID NOT HAVE SPECIFICS WHEN THESE LEAKS OCCURRED (INCIDENT DATES). ACCORDING TO THE CUSTOMER, THE DEVICES WERE FILLED WITH 5-FLUOROURACIL AND D5W (UNKNOWN CONCENTRATIONS). THE FACILITY CONNECTS A 12 INCH NON-BAXTER EXTENSION SET ON THE DEVICE FOR USE OF A SLIDE CLAMP (THE BAXTER INFUSOR DOES NOT HAVE A SLIDE CLAMP TO STOP FLOW). THE MANUFACTURER OF THE EXTENSION SET IS UNKNOWN PER THE CUSTOMER. ACCORDING TO THE CUSTOMER, THE DEVICES ARE THEN STORED IN A ZIPLOC BAG AND SENT TO THE PATIENT. UPON RECEIPT OF THE SAMPLES, IT WAS OBSERVED MOISTURE/FLUID WAS COLLECTING WITHIN THE ZIPLOC BAGS. THE FACILITY THOUGHT THE LEAK WAS COMING FROM THE CONNECTION SITE OF THE EXTENSION SET AND THE INFUSOR BUT THEY VERIFIED CONNECTION AND STILL COULD NOT STOP THE LEAKING. THE CUSTOMER STATED THEY HAVE SINCE STOPPED USING THE EXTENSION SETS AND HAVE NOT WITNESSED ANY LEAKS. THE DEVICES WERE NOT USED FOR PATIENT THERAPY. THEREFORE NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 5 WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV 5, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK EXTENSION SET| EXTENSION SET| 5% DEXTROSE| 5-FLUOROURACIL