BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2080906 · Received May 7, 2011

    Report

    Report Number
    6000001-2011-03778
    Event Type
    Malfunction
    Date Received
    May 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW HAS BEEN PERFORMED AND THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS REPORT. THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME. THE ROOT CAUSE WILL CONTINUE TO BE INVESTIGATION THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER (B)(4) TO REPORT AN INTERMATE IN WHICH THE RESERVOIR RUPTURED. THE EVENT OCCURRED DURING FILLING. THE FACILITY REPRESENTATIVE REPORTED ONE UNIT TO BAXTER. TWO UNITS WERE RECEIVED AS SAMPLES TO BAXTER FOR EVALUATION. THIS COMPLAINT IS FOR THE SECOND UNIT THAT WAS RECEIVED BY BAXTER FOR EVALUATION. THERE IS 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, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10N063

    Patients

    Seq Age Sex Outcome Treatment
    1