BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2243565 · Received August 26, 2011

    Report

    Report Number
    9610825-2011-00110
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 26, 2011
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT # (B)(4). DEVICE EVAL RESULTS: THE PUMP LOG WAS REVIEWED AND TWO SEPARATE INFUSIONS OF 100ML AND 191.4ML AT A 200ML/HR RATE WERE IDENTIFIED. THE FIRST INFUSION RAN TO COMPLETION WITH A TOTAL VOLUME INFUSED OF 100.1ML OR 100.1% OF THE TARGET VOLUME. THE SECOND INFUSION WAS STOPPED AFTER 36MIN 9SEC BECAUSE OF AN AIR ALARM. AT THAT TIME, A TOTAL VOLUME OF 120.5ML WAS INFUSED, WHICH IS EQUAL TO 100% OF THE THEORETICAL VOLUME. THESE RESULTS WERE BOTH WITHIN SPEC. VOLUMETRIC ACCURACY WAS ALSO TESTED THREE TIMES AT A RATE OF 200ML/HR AND A VOLUME TO BE DELIVERED OF 100ML, CONSISTENT WITH THE PUMP LOG WHEN THE ISSUE WAS IDENTIFIED. IN ALL THREE INSTANCES, THE PUMP WAS OPERATING WITHIN SPEC AND DELIVERED THE TARGET VOLUME WITH RESULTS OF 97.5ML, 97.4ML, AND 97.6ML RESPECTIVELY. AS A RESULT OF THE ANALYSIS, THE EVENT DESCRIBED COULD NOT BE CONFIRMED ON THE RETURNED PUMP. BASED ON THE RESULTS OF THE PUMP INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE ACTUAL MFR FOR FURTHER EVAL. A FOLLOW-UP REPORT WILL BE FILED IF ADD'L PERTINENT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: UNDERINFUSED. DRUG BEING ADMINISTERED WAS AN ANTIBIOTIC. NAME OF ANTIBIOTIC UNAVAILABLE. INTERMITTENT INFUSION. PUMP INFUSION FOR 30 MINUTES PRIOR TO OCCURRENCE. TWO HUNDRED FIFTY ML'S OF SOLUTION WAS LEFT IN IV CONTAINER. NO INJURY.

    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 UNK Other