BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2260189 · Received September 22, 2011

    Report

    Report Number
    6000001-2011-26312
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    January 30, 2011
    Report Date
    September 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF NO FLOW WAS CONFIRMED. VISUAL EXAMINATION OF THE UNIT NOTED EXCESSIVE WHITE DRUG PRECIPITATE INSIDE THE BLADDER AND DELIVERY TUBING. CRYSTALLIZED DRUG WAS ALSO NOTED BLOCKING THE END OF THE GLASS CAPILLARY (FLUID PATHWAY) LOCATED INSIDE THE FLOW RESTRICTOR. A FUNCTIONAL TEST WAS ATTEMPTED BY FILLING THE BLADDER WITH WATER. AFTER FILL, NO EVIDENCE OF FLOW WAS NOTED AT THE DISTAL LUER DUE TO BLOCKAGE FROM THE CRYSTALLIZED DRUG INSIDE THE DELIVERY TUBING. FORCED PRIME WAS ATTEMPTED, BUT FLOW CONTINUED TO FAIL. THE ROOT CAUSE WAS DETERMINED TO BE DRUG CRYSTALLIZATION AT THE END OF THE GLASS CAPILLARY. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, THIS PRODUCT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR HAD NO FLOW BEFORE PATIENT CONNECTION. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. 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 09N004

    Patients

    Seq Age Sex Outcome Treatment
    1