BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 2970247 · Received February 12, 2013

    Report

    Report Number
    9610825-2013-00013
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 23, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MEDICAL, INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4). THE ACTUAL DEVICE INVOLVED IN THE EVENT HAS BEEN RECEIVED IN (B)(4), AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION (B)(6)): INFUSED CORRECTLY - UNDERINFUSION. THIS PUMP INFUSED PROPOFOL WHILE PUMP NO. 1 WAS INFUSING. THE CUSTOMER DOES NOT KNOW WHICH OF THESE TWO PUMPS MADE ALL THREE PTS MOVE. WHEN THE PUMP ARRIVED AT CLINICAL ENGINEERING AT THE HOSPITAL, THE SYRINGE THAT WAS ATTACHED TO THE PUMP WAS PROPOFOL. THE SYRINGE HAD 20 ML LEFT. THE SYRINGE WAS MARKED WITH 10 MG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62113 PERFUSOR SPACE INFUSION SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other