BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2233689 · Received September 2, 2011

    Report

    Report Number
    6000001-2011-22541
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. HOWEVER, A PORTION OF THE LUER WAS NOT RETURNED WITH THE DEVICE FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THE REPORTED CONDITION OF BROKEN DISTAL LUER. BASED ON THE EVALUATION, BROKEN/CRACKED LUER NEAR THE BASE OF THE STEM IS DUE TO STRESS FROM THE PACKAGING DESIGN. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE SAMPLE. 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INTERMATE HAD AN UNSPECIFIED PROBLEM. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION, BAXTER SERVICE PERSONNEL REPORTED THAT THE LUER WAS BROKEN. 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 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 09N071

    Patients

    Seq Age Sex Outcome Treatment
    1