BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3760012 · Received April 18, 2014

    Report

    Report Number
    1416980-2014-12692
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. EVALUATION INFORMATION: THE DEVICE WAS FOUND TO OPERATE WITHIN SPECIFICATION. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). ONE ACTUAL UNIT WAS RECEIVED WITH 5ML OF FLUID IN ITS BLADDER. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED ON THE UNIT. THE FLOW RATES WERE FOUND TO BE WITHIN THE SPECIFICATION RANGE FOR THE PRODUCT. THE INITIAL EVALUATION COULD NOT CONFIRM THE REPORTED CONDITION. A BATCH REVIEW WILL BE PERFORMED. IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AN UNDERINFUSION WAS REPORTED DURING THE USE OF AN INFUSOR ELASTOMERIC DEVICE. THE EXPECTED INFUSION TIME WAS 46 HOURS, THOUGH SOME SOLUTION REMAINED IN THE DEVICE AFTER APPROXIMATELY 58 HOURS. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION WAS ASSOCIATED WITH THE EVENT. THE INFUSOR DEVICE WAS FILLED WITH 72ML OF 5-FU AND 5ML OF SALINE (NOT BAXTER PRODUCTS). NO ADDITIONAL INFORMATION REGARDING THIS EVENT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238385 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13G038

    Patients

    Seq Age Sex Outcome Treatment
    1 5ML OF NORMAL SALINE| 72ML OF FLUOROURACIL