BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 5674163 · Received May 23, 2016

    Report

    Report Number
    9610825-2016-00309
    Event Type
    Malfunction
    Date Received
    May 23, 2016
    Date of Event
    April 7, 2016
    Report Date
    May 4, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. 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). RESULT OF EXAMINATION BY OUR SALES ORGANIZATION : THE PROVIDED SAMPLE WAS TESTED ACCORDING THE REQUIREMENTS OF TECHNICAL SAFETY CHECK AS WELL AS A FLOW TEST WAS PERFORMED. CONCLUSION: THE DEVICE IS WORKING ACCORDING TO ITS SPECIFICATION.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. 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 THE DEVICE WILL NOT SHIPPED TO B. BRAUN MELSUNGEN AG FOR INVESTIAGTION. THE INVESTIGATION RESULTS WILL BE PROVIDED BY OUR SALES ORGANISATION. 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 (B)(4)): OVER INFUSION: ACCORDING TO THE CUSTOMER COMPLAINT:"PUMP INFUSOMAT SPACE SERIES (B)(6)-IT WAS REPORTED THAT THERE WAS A CHANGE PROGRAMMING 1ML/H TO 60 ML/H.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329090 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1