BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2233697 · Received September 2, 2011

    Report

    Report Number
    6000001-2011-22551
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE CONDITION OF A LEAK AT THE JUNCTION OF THE TUBING AND THE STRESS-MEMBER WAS CONFIRMED. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGN OF PHYSICAL ABNORMALITY. THE UNIT WAS SUBSEQUENTLY LEAK TESTED. LEAK WAS NOTED AT THE JUNCTION OF THE TUBING AND THE STRESS-MEMBER. THE ROOT CAUSE WAS DETERMINED TO BE INSUFFICIENT BONDING AT THE SEAL BETWEEN THE TUBING AND STRESS MEMBER. THE BOND POCKET OPTIMIZATION PROJECT WAS INITIATED TO IMPROVE THE STRESS MEMBER AND RESTRICTOR HOUSING. A LONGER SEAL LENGTH RESULTS IN A LARGER CONTACT SURFACE FOR SOLVENT TO BOND AND HENCE A LOWER CHANCE OF LEAK. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. 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.

    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 DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    BAXTER SERVICE PERSONNEL REPORTED AN INFUSOR WHICH LEAKED AT THE JUNCTION OF THE TUBING AND STRESS-MEMBER. THIS CONDITION OCCURRED WHEN THE DEVICE WAS FILLED DURING EVALUATION. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY OR BREACH THE STERILE FLUID PATHWAY. 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 10J051

    Patients

    Seq Age Sex Outcome Treatment
    1