BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 6491117 · Received April 13, 2017

    Report

    Report Number
    9610825-2017-00071
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Date of Event
    March 13, 2017
    Report Date
    March 22, 2017
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    0404693716752
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN ALREADY PROVIDED BY USER FACILITY FOR INVESTIGATION AT BBM LABORATORY IN MELSUNGEN, GERMANY. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN GERMANY): OVER INFUSION

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016018. (B)(4). RESULT OF EXAMINATION: THE HISTORY LOG FILES OF THE RECEIVED SAMPLE WERE READ OUT AND ANALYZED. THE HISTORY FILES REVEALED NO ABNORMALITIES REGARDING THE REPORTED EVENT. THEREUPON THE INFUSOMAT SPACE WAS VISUALLY AND FUNCTIONALLY EXAMINED. THE SAMPLE WAS SLIGHTLY CONTAMINATED AND SHOWED SIGNS OF A DROP DAMAGE. THE SPACELINE, WHICH WAS ENGAGED FOR TESTING PURPOSES, WAS DEPENDABLY IDENTIFIED AND COULD BE SELECTED. A START-UP WAS POSSIBLE WITHOUT RESERVATIONS. HOWEVER, THE MECHANICAL PRESSURE LIMITATION DID NOT MEET THE REQUIREMENTS OF THE TECHNICAL SAFETY CHECK. IT WAS TRIED TO CALIBRATE THE DEVICE. THIS PROCEDURE WAS NOT POSSIBLE, BECAUSE THE DOOR BOLT DID NOT REACH THE "OPEN" POSITION. THEREFORE A DELIVERY ACCURACY MEASUREMENT WAS NOT POSSIBLE. THE DEVICE WAS OPENED AND THE INSIDE WAS EXAMINED. THE DEVICE WAS DAMAGED MASSIVELY INSIDE. FOLLOWING IS DESCRIBED IN THE IFU: PRIOR TO ADMINISTRATION, VISIBLY INSPECT THE PUMP FOR DAMAGE, MISSING PARTS OR CONTAMINATION AND CHECK AUDIBLE AND VISIBLE ALARMS DURING SELF TEST. IF THE PUMP FALLS DOWN OR IS EXPOSED TO FORCE, IT MUST BE CHECKED BY THE SERVICE DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271870 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG N/A N/A 0404693716752

    Patients

    Seq Age Sex Outcome Treatment
    1