BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 2850256 · Received October 12, 2012

    Report

    Report Number
    9610825-2012-00202
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 19, 2012
    Report Date
    October 12, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4). THE DEVICE IS CURRENTLY ON SHIPPING FROM USER FACILITY TO BBM LABORATORY IN (B)(4) FOR INVESTIGATION. 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 IN (B)(4)): THE SYRINGE PUMP DID NOT INFUSE MEDICINE INTO THE PT AND AS A CONSEQUENCE, THE PT'S BLOOD PRESSURE SANK. THERE WAS HOWEVER NO FALSE ALARM GIVEN BY THE PUMP. IMMEDIATELY AFTER THIS EVENT THE PHYSICIAN TRIED TO GIVE A BOLUS INJECTION IN ORDER TO RAISE THE BLOOD PRESSURE, BUT EVEN THIS DID NOT WORK. THE TUBING WAS DISCONNECTED FROM THE PT IN ORDER TO CHECK ITS FUNCTIONALLY AND IT SEEMED THAT THE FLOW RATE WAS NOT 29 ML/H AS EXPECTED. FINALLY THE SYRINGE WAS OPERATED MANUALLY AND THE BLOOD PRESSURE WAS NORMALISED. THE PT WAS EXPOSED TO A POTENTIALLY HAZARDOUS SITUATION. THE EVENT WAS REPORTED IN THE HOSPITAL'S INTERNAL OBSERVATION SYSTEM ((B)(6)) BY THE OPERATING NURSE. THE TUBING, AS WELL ALL THE RELEVANT GADGETS, WAS CHECKED SEVERAL TIMES AND THE OUTCOME WAS THAT THE SYRINGE PUMP DID NOT WORK PROPERLY. THE BOLUS BUTTON WORKS BUT IT FEELS VERY STIFF AND HAS TO BE PUSHED HARD IN ORDER TO HAVE A RESPONSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other