BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 6095475 · Received November 11, 2016

    Report

    Report Number
    9610825-2016-00704
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Report Date
    December 23, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). BASED ON THE RESULTS OF THE INVESTIGATION, THE PUMP WOULD NOT OPERATE ON BATTERY POWER, FURTHER EVALUATION WAS UNABLE TO BE PERFORMED. FLUID WAS CLEANED FROM THE POWER CONNECTOR TO CORRECT THE ISSUE. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE SPACE PUMP STATE: "TO PROTECT THE PUMP AND POWER SUPPLY FROM MOISTURE". BASED ON THE INFORMATION PROVIDED BY OUR SERVICE PROVIDER, THE REPORTED EVENT WAS ATTRIBUTED TO USE ERROR. ALL INFORMATION CONCERNING THIS REPORTED INCIDENT HAS BEEN INCLUDED IN OUR TREND ANALYSIS OF THE PRODUCT LINE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE DEVICE INVOLVED HAS BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE PUMP WAS NOT INFUSING FLUIDS. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746524 INFUSOMAT SPACE NFUSION PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1