BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2162853 · Received July 15, 2011

    Report

    Report Number
    6000001-2011-12029
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 19, 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 WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING APPROXIMATELY 110 ML OF SOLUTION IN THE BLADDER. THE REPORTED CONDITION OF NO FLOW/NON-DELIVERY WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE DEVICE 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 SAMPLE. 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. 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

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR HAD DELIVERY STOP DURING PATIENT USE. THE PATIENT OBSERVED THAT DELIVERY STOPPED AFTER 10 ML HAD INFUSED. THE SALES REPRESENTATIVE ALSO OBSERVED NO FLOW FROM THE DEVICE. THE DEVICE WAS FILLED WITH A SOLUTION OF 5-FLUOROURACIL AND SALINE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. THE SAMPLE IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 11A008

    Patients

    Seq Age Sex Outcome Treatment
    1 5-FLUOROURACIL| SALINE