BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 6234369 · Received January 9, 2017

    Report

    Report Number
    9610825-2016-00891
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Report Date
    December 6, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046963716745
    PMA / PMN Number
    K092313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    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). MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE PUMP AND/OR LOGS. NO ADDITIONAL INFORMATION WAS RECEIVED; BECAUSE OF THIS, FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE AND NO CONCLUSION COULD BE DRAWN. IF A SAMPLE AND/OR ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE PUMP OVER INFUSED. THE PUMP WAS SET TO INFUSE IN 30 MINUTES AND THE PUMP COMPLETED THE INFUSION IN 19 MINUTES. LIMITED INFORMATION PROVIDED AT THIS TIME. UNKNOWN IF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16776 PERFUSOR® SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG 04046963716745

    Patients

    Seq Age Sex Outcome Treatment
    1