BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR,LV 2 ML/H 12 PACK

    MDR report key: 1973269 · Received January 28, 2011

    Report

    Report Number
    6000001-2011-00511
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 4, 2011
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE FILLED UNIT WAS RECEIVED BY BAXTER FOR EVALUATION CONTAINING NO FLUID IN THE BLADDER. VISUAL EXAMINATION OF THE UNIT SHOWED NO SIGNS OF DEFECT OR ABNORMALITY. THE UNIT WAS SUBSEQUENTLY FILLED WITH WATER TO ITS MAXIMUM VOLUME. DURING AND AFTER FILL, NO EVIDENCE OF LEAK OR BACKFLOW WAS OBSERVED AT THE FILLPORT. THE UNIT PERFORMED AS EXPECTED. THEREFORE, THE REPORTED CONDITION OF "BACKFLOW" COULD NOT BE CONFIRMED AND AN ASSIGNABLE ROOT CAUSE COULD NOT BE IDENTIFIED. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) CE INFUSOR DEVICE WAS OBSERVED LEAKING AT THE FILL PORT DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITINOAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR,LV 2 ML/H 12 PACK PUMP, INFUSION, ELASTOMERIC MEB 09J067

    Patients

    Seq Age Sex Outcome Treatment
    1