BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 5638006 · Received May 6, 2016

    Report

    Report Number
    9610825-2016-00280
    Event Type
    Malfunction
    Date Received
    May 6, 2016
    Date of Event
    April 19, 2016
    Report Date
    April 29, 2016
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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). THE VOLUMETRIC ACCURACY WAS TESTED THREE TIMES AT 19.8ML/HR AND 19.8ML WITH 60ML SYRINGE. THE TEST RESULTS WERE WITHIN SPECIFICATIONS. BASED ON THE RESULTS OF THE INVESTIGATION AND LOG REVIEW, THE PUMP OPERATED AS INTENDED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    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 MEDICAL INC INTERNAL REPORT (B)(4). THE ACTUAL DEVICE HAS NOT BEEN RECEIVED YET AND THE INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE PROVIDED WHEN THE EVALUATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: END USER WITH CLINICAL TRIAL HAS A PERFUSOR SPACE PUMP THAT WAS UNDER INFUSING ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291617 PERFUSOR SPACE INFUSION PUMP FRN B.BRAUN MELSUNGEN AG N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1