BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2120673 · Received June 10, 2011

    Report

    Report Number
    6000001-2011-07496
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 17, 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). 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 FOR EVALUATION. THE REPORTED CONDITION OF AN UNDERINFUSION WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGNS OF PHYSICAL ABNORMALITY. FLOW WAS READILY OBSERVED AT THE LUER UPON SAMPLE RECEIPT. THE SOLUTION IN THE BLADDER WAS ALLOWED TO DRAIN UNTIL EMPTIED. ONCE EMPTIED, 97 ML OF SOLUTION WAS COLLECTED FROM THE BLADDER. AN ACCURACY FLOW TEST WAS PERFORMED ON THE UNIT FOR 42 HOURS. AT THE END OF THE FLOW TEST PERIOD, THE UNIT PRODUCED THE FOLLOWING FLOW RATES: CALCULATED FLOW RATE = 1.85 ML/HR. NORMALIZED FLOW RATE = 1.90 ML/HR. SPECIFICATION RANGE = 1.80 - 2.20 ML/HR. THE INFUSOR PRODUCED FUNCTIONAL RESULTS WITHIN THE SPECIFICATION RANGE; THE DEVICE PERFORMED AS EXPECTED. NO ROOT CAUSE WAS IDENTIFIED. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. 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 REPORTEDLY UNDERINFUSED DURING THE PATIENT USE. THE ACTUAL FLOW RATE WAS UNKNOWN. AFTER 2 DAYS, IT SEEMED THAT THE BLADDER DID NOT DEFLATE. THE TOTAL FILL VOLUME WAS 92CC: 5-FLUOROURACIL AND SALINE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY AND MEDICAL INTERVENTION. THE ACTUAL SAMPLE IS AVAILABLE. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10K090

    Patients

    Seq Age Sex Outcome Treatment
    1 5-FLUOROURACIL| SALINE