BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN-DAY INFUSOR

    MDR report key: 320542 · Received March 8, 2001

    Report

    Report Number
    6000001-2001-00093
    Event Type
    Malfunction
    Date Received
    March 8, 2001
    Date of Event
    February 7, 2001
    Report Date
    February 9, 2001
    Manufacturer
    IRVINE
    Product Code
    MEB
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS A 0.5ML/HR SEVEN-DAY INFUSOR OVERINFUSED APPROX 79ML OF THE TOTAL 84ML FILL VOLUME DURING HOME INFUSION. THE UNIT WAS FILLED WITH 70ML OF 5FU AND 14ML OF SALINE. REPORT STATES THE UNIT WAS ATTACHED TO THE PT ON THE DAY OF THE EVENT AT 1300. 48 HOURS LATER AT 1300, THE PT OBSERVED "FEW DRUGS" IN THE RESERVOIR. THE PT WENT TO THE HOSPITAL WHERE THE DR CONFIRMED THE VOLUME REMAINING IN THE RESERVOIR WAS 5ML. THE DR EXAMINED THE PT'S WHITE BLOOD CELL COUNT AND CONFIRMED NO INCREASE. DR REPORTS PT WAS NOT INJURED. ANOTHER INFUSOR CONTAINING 5FU WAS GIVEN TO THE PT, AND THE PT RETURNED HOME. THE PT'S BLOOD LEVELS WERE FOUND "NORMAL" BY THE PT'S DR DURING A FOLLOW-UP EXAMINATION 2 WKS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10093 SEVEN-DAY INFUSOR ELASTOMETIC INFUSION SYSTEM MEB IRVINE NA 00J004

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR