BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDMATE

    MDR report key: 26994 · Received October 16, 1995

    Report

    Report Number
    MW1007339
    Event Type
    Malfunction
    Date Received
    October 16, 1995
    Date of Event
    October 2, 1995
    Report Date
    October 4, 1995
    Manufacturer
    PATIENT SOLUTIONS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CLINDAMYCIN 2700MG DILUTED IN 270ML NORMAL SALINE. ATTACHED TO INFUSION PUMP TO DELIVER 900MG/90ML OVER 30 MINUTES ONCE EVERY 8 HRS. BAG TO BE CHANGED DAILY.THE THERAPY HAD BEEN IN PLACE 7 DAYS WITHOUT MAJOR INCIDENT. AT ABOUT 7 HRS INTO A 24 HR BAG, IT WAS REPORTED THAT THE BAG WAS EMPTY. THE PUMP SCREEN READ THAT 90 ML HAD BEEN INFUSED. BUT VISUAL INSPECTION INDICATED THAT MORE THAN 250ML HAD BEEN INFUSED. THE INFUSION WAS DISCONTINUED, PHYSICIAN & POISON CONTROL CENTER WERE NOTIFIED. MFR WAS CONTACTED (MEDICATION). THE PUMP WAS RETURNED TO THE MFR FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDMATE AMBULATORY INFUSION PUMP FRN PATIENT SOLUTIONS, INC. MEDMATE 1100

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other