BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 6171748 · Received December 13, 2016

    Report

    Report Number
    1416980-2016-18328
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    October 3, 2016
    Report Date
    December 13, 2016
    Manufacturer
    BAXTER HEALTHCARE- IRVINE
    Product Code
    FRN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INTERMATE DID NOT FULLY INFUSE. THE INTERMATE WAS FILLED WITH 700 MG OF ALPHALASTIN. THE EXPECTED INFUSION TIME WAS 1 HOUR, AFTER DISCONNECTING THE INTERMATE, 1/3 OF SOLUTION REMAINED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822374 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE- IRVINE NA 16A007

    Patients

    Seq Age Sex Outcome Treatment
    1 700 MG ALPHALASTIN