BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE ACM-KIT

    MDR report key: 3952670 · Received July 17, 2014

    Report

    Report Number
    2523676-2014-00280
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    July 8, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: OVER INFUSION; PUMP PROGRAMMED 4 ML PER HOUR ADMINISTERED 10 ML PER HOUR, DRUG USED IS UNKNOWN. NO PATIENT INJURY REPORTED. MFR - 9610825-2014-00280.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420116 PERFUSOR SPACE ACM-KIT INFUSION SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK