BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2850288 · Received October 24, 2012

    Report

    Report Number
    9610825-2012-00215
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    August 27, 2012
    Report Date
    October 24, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). B. BRAUN MEDICAL, INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN (B)(4) (THE MANUFACTURER), AND (B)(4) (THE IMPORTER). (B)(4). THE ACTUAL PUMP INVOLVED IN THE REPORTED INCIDENT WAS RETURNED FOR EVALUATION. THE REPORTED INCIDENT OF PUMP STOPPING WHILE INFUSING WAS CONFIRMED, HOWEVER THE DELAY OF THERAPY WITHOUT ALARM WAS NOT CONFIRMED. WHEN ATTEMPTING TO PERFORM THE INITIAL TESTING OF THE PUMP, THE INFUSION WAS INTERRUPTED WITH A SYSTEM ALARM, THE KEYPAD DID NOT RESPOND AND NO CONNECTION OR COMMUNICATION WITH THE (B)(4) PROGRAM COULD BE ESTABLISHED. THE PUMP WAS NOT OPERABLE. THE MOTHERBOARD, PART NUMBER (B)(4), WAS REPLACED. THE PUMP WAS THEN RETESTED AND THE PUMP MET ALL TESTING REQUIREMENTS. THE PUMP'S LOG WAS REVIEWED. THE LOG DID NOT HAVE ANY DATA FOR THE DAY OF THE EVENT, (B)(6) 2012. THE OPERATION LOG DATA APPEARS TO HAVE BEEN CORRUPTED AND NO DATA WAS RECORDED IN THE LOG AFTER (B)(6) 2012. HOWEVER, THE ALARM LOG DID RECORD A SYSTEM ERROR ON (B)(6) 2012 AT 5:30:09 PM ON THE DATE OF THE REPORTED EVENT. A HISTORICAL REVIEW OF THE CUSTOMER COMPLAINT DATABASE, DATING BACK (B)(4) REVEALED NO ADVERSE TRENDS OF THIS NATURE AGAINST PART NUMBER (B)(4) OR PART NUMBER (B)(4). BASED ON THE RESULTS OF THIS INVESTIGATION, NO SPECIFIC CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE EVENT. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: DELAYED THERAPY WITHOUT ALARM. PUMP TURNED OFF WITHOUT ALARMING AND STOPPED INFUSION. CARE AREA: NICU/PICU, PUMP IN CONTINUOUS MODE TO INFUSE 0.86 ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1