BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-DAY INFUSOR

    MDR report key: 324020 · Received March 28, 2001

    Report

    Report Number
    6000001-2001-00132
    Event Type
    Malfunction
    Date Received
    March 28, 2001
    Date of Event
    February 7, 2001
    Report Date
    February 28, 2001
    Manufacturer
    IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS 2 INFUSORS CONTAINING 42MG OF ADRIAMYCIN IN SALINE TO A TOTAL VOLUME OF 12ML OVERINFUSED. 1 UNIT INFUSED OVER 12 HOURS. 1 UNIT INFUSED OVER 18 HOURS. CUSTOMER ANTICIPATED INFUSION DURATION OF 24 HOURS. REGARDING THE INFUSION OF 12 HOURS, THE RPH STATES THE PT WENT HOME NOT NOTICED DEVICE WAS EMPTY EARLY. AS A RESULT, THE PT CALLED THE DOCTOR AND CAME INTO THE DOCTORS OFFICE THE NEXT FOR A NEW INFUSOR AND TO HAVE THE LINE FLUSHED. NO SIMILAR DETAILS PROVIDED THE 18 HOUR INFUSION. PER RPH, THERE WAS NO PT INJURY OR MEDICAL INTERVENTION RESULTING FOR EITHER OF THE REPORTED OVERINFUSIONS. 12 HOUR INFUSION OCCURRED IN 2001, 18 HOUR INFUSION OCCURRED ONE WEEK LATER. BOTH INVOLVED THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13898 MULTI-DAY INFUSOR ELASTOMERIC INFUSION SYSTEM MEB IRVINE NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN