BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2173595 · Received July 23, 2011

    Report

    Report Number
    6000001-2011-13619
    Event Type
    Malfunction
    Date Received
    July 23, 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. THE REPORTED CONDITION OF A BROKEN BLUE CAP WAS NOT CONFIRMED. HOWEVER, VISUAL EXAMINATION OF THE SAMPLE NOTED A BROKEN DISTAL LUER. NO ROOT CAUSE WAS IDENTIFIED, AS NO EVIDENCE OF BROKEN BLUE CAP 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. 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED BUT NOT YET RECEIVED FOR EVALUATION. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER (B)(4) TO REPORT AN INTERMATE IN WHICH THE BLUE CAP WAS BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 09N023

    Patients

    Seq Age Sex Outcome Treatment
    1