BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE ACM-KIT

    MDR report key: 4003304 · Received July 31, 2014

    Report

    Report Number
    9610825-2014-00298
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 23, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K083689
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE HAS NOT BEEN RECEIVED YET FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY. CUSTOMER REPORTS UNDER INFUSION: NO ALARM OCCURRED DURING INFUSION. INFUSING CEFUXIMAB, 520 ML TO INFUSE OVER 20 HOURS RATE SET FOR 210 ML PER HOUR. APPEARED TO BE INFUSING CORRECTLY, NO ALARMS DURING INFUSION. NURSE CHECKED BAG WHEN INFUSION SUPPOSED TO END, NOTED 1/2 THE BAG REMAINED, INFUSED OVER A SECOND 2 HOURS. CUSTOMER DID CALCULATE DRIP RATE AT TIME NOTED BAG ABOUT 1/2 FULL AND DRIP RATE CALCULATED OUT TO HALF OF THE SET RATE. CUSTOMER REPORTS THIS DRUG IS VERY VISCOUS, BUT HAVE INFUSED IT OTHER TIMES WITH NO ISSUES USING PUMP, SET USED 490041. CUSTOMER DID NOT SAVE SET OR BAG DUE TO NATURE OF THE DRUG. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449221 INFUSOMAT SPACE ACM-KIT INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN