BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2110847 · Received June 2, 2011

    Report

    Report Number
    6000001-2011-06953
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING APPROXIMATELY 180 ML OF SOLUTION IN THE BLADDER. THE REPORTED CONDITION OF NO FLOW/NON-DELIVERY WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE UNIT SHOWED NO SIGNS OF BLOCKAGE THAT COULD HAVE CAUSED THE REPORTED CONDITION. FLOW WAS READILY OBSERVED AT THE LUER. FLOW CONTINUED WITHOUT STOPPING UNTIL THE SOLUTION WAS EMPTIED FROM THE BLADDER. NO SIGNS OF DEFECT WERE NOTED FROM THE INFUSOR DEVICE. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT ONE (1) INFUSOR DEVICE DID NOT FLOW DURING FILLING. . NO FORCE PRIMING ATTEMPTED. THE DEVICE WAS FILLED WITH 5-FU AND SALINE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY AND MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10J100

    Patients

    Seq Age Sex Outcome Treatment
    1 5-FLUOROURACIL| SALINE