BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2182898 · Received July 28, 2011

    Report

    Report Number
    6000001-2011-15278
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 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 DEVICE FOR EVALUATION. THE REPORTED CONDITION OF A BROKEN SYRINGE TIP INSIDE THE FILL PORT WAS CONFIRMED. VISUAL EXAMINATION OF THE UNIT CONFIRMED A BROKEN TIP OF THE SYRINGE STUCK INSIDE OF THE FILL PORT. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. 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. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: 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 SERVICE PERSONNEL REPORTED AN INFUSOR IN WHICH THE TIP OF A GLASS FILLING SYRINGE BROKE IN THE FILL PORT. THIS CONDITION OCCURRED DURING EVALUATION. THE GLASS SYRINGE WAS NOT RETURNED WITH THE UNIT FOR 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. 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 10N052

    Patients

    Seq Age Sex Outcome Treatment
    1