BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, PCA

    MDR report key: 3556031 · Received January 6, 2014

    Report

    Report Number
    1416980-2014-00628
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 6, 2013
    Report Date
    December 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE PCM UNIT WAS RECEIVED AT THE PLANT FOR EVALUATION. THE UNIT WAS CONNECTED TO AN INFUSOR UNIT. A VISUAL INSPECTION WAS CONDUCTED WITH NO ISSUES DETECTED. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED AND THE UNIT WAS FOUND TO BE WORKING WITHIN SPECIFICATION. FLOW WAS OBSERVED AT THE LUER DURING THE ENTIRE COURSE OF THE FLOW RATE TEST PERIOD. THE REPORTED PROBLEM WAS NOT CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED BETWEEN JUNE 21, 2013 AND JULY 2, 2013. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE HAS BEEN RECEIVED BY BAXTER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT CONTROL MODULE DID NOT ALLOW FLOW OF SOLUTION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5526 PUMP, INFUSION, PCA MEA BAXTER HEALTHCARE - IRVINE 13F058

    Patients

    Seq Age Sex Outcome Treatment
    1 LARGE VOLUME INFUSOR