BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 4821851 · Received June 5, 2015

    Report

    Report Number
    9610825-2015-00212
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Report Date
    May 26, 2015
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY UNDER INVESTIGATION AT OUR (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED WHEN THE EXAMINATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT OF EXAMINATION: THE HISTORY LOG FILES OF THE RECEIVED SAMPLE WERE READ OUT AND ANALYZED. NO HINTS FOR A DEVIATION OF THE DELIVERY ACCURACY WERE FOUND. THEREUPON THE INFUSOMAT SPACE WAS SUBJECTED TO A VISUAL AND FUNCTIONAL EXAMINATION. NO EXTERNAL DAMAGES WERE FOUND. THE DEVICE SHOWED AGE-BASED MARKS OF USE AND SOME CONTAMINATION. THE SPACELINE, WHICH WAS ENGAGED FOR TECHNICAL PURPOSES, WAS DEPENDABLY IDENTIFIED AND COULD BE SELECTED. A START-UP WAS POSSIBLE WITHOUT RESERVATIONS. FOR CHECKING THE DELIVERY ACCURACY THE DEVICE WAS TESTED ACCORDING TO THE REQUIREMENTS OF THE TECHNICAL SAFETY CHECK THREE TIMES AND A MEASUREMENT ACCORDING TO (B)(4) WAS PERFORMED. ALL MEASURED VALUES WERE WITHIN SPECIFICATION. THE PUMP OPERATED AS INTENDED AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. BASED ON THE RESULTS OF THIS INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY ((B)(4)): PUMP INCORRECTLY INFUSED POTASSIUM IN 2 HOURS RATHER THAN OVER 10 HOURS. NO EVIDENCE OF ANY HARM TO THE PATIENT, NO DELAY TO THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365683 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG N/A

    Patients

    Seq Age Sex Outcome Treatment
    1