BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 5875992 · Received August 15, 2016

    Report

    Report Number
    9610825-2016-00560
    Event Type
    Malfunction
    Date Received
    August 15, 2016
    Date of Event
    July 27, 2016
    Report Date
    July 27, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    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) A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    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) 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY ((B)(4)): OVER INFUSION. ACCORDING TO THE CUSTOMER COMPLAINT: "IT STARTED INFUSION OF HEPARIN 0.3ML/H, BUT OBSERVED THAT ONCE WAS INFUSED 5ML".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529643 PERFUSOR SPACE SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1