BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3163491 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-15039
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 20, 2013
    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). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL EXAMINATION OF THE INFUSOR SAMPLE SHOWED NO SIGNS OF LEAKAGE. WHEN THE NON-BAXTER CONNECTOR WAS ATTACHED TO THE INFUSOR'S LUER, LEAKAGE WAS OBSERVED AT THE CONNECTION BETWEEN THE CONNECTOR AND THE INFUSOR'S LUER. WHEN THE CONNECTOR WAS NOT ATTACHED TO THE INFUSOR'S LUER, NO EVIDENCE OF LEAK WAS OBSERVED. BASED ON THE EVALUATION FINDINGS, THE REPORTED LEAK CONDITION WAS NOT CONFIRMED ON BAXTER'S INFUSOR UNIT. NO ROOT CAUSE WAS IDENTIFIED, AS NO EVIDENCE OF BAXTER PRODUCT MALFUNCTION WAS OBSERVED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFUSOR LEAKED AT THE CONNECTION OF THE LUER LOCK AND THE NON-BAXTER INFECTION PREVENTION CONNECTOR DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264729 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13A009

    Patients

    Seq Age Sex Outcome Treatment
    1 NON-BAXTER INFECTION PREVENTION CONNECTOR