BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 6170156 · Received December 13, 2016

    Report

    Report Number
    1416980-2016-18312
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 17, 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
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION WITH APPROXIMATELY 100ML OF FLUID IN THE BLADDER. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED AND THE DEVICE OPERATED WITHIN SPECIFICATION. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME INTERMATE HAD NOT INFUSED ANY MEDICATION AFTER 5 MINUTES. THE DEVICE WAS FILLED WITH 640 MG OF TOBRAMYCIN IN 100ML OF 0.9% SODIUM CHLORIDE. 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
    821626 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE- IRVINE NA 16F038

    Patients

    Seq Age Sex Outcome Treatment
    1 TOBRAMYCIN IN SODIUM CHLORIDE