BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2932441 · Received January 17, 2013

    Report

    Report Number
    9610825-2012-00297
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 19, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FPA
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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). IN A FOLLOW UP CALL TO THE FACILITY, THE REPORTER STATED THAT A 100 ML BAG WAS USED FOR THE INFUSION. THE PUMP WAS SET TO INFUSE 80 ML AT A RATE THAT IS UNKNOWN. THE PUMP ALARMED FOR THE COMPLETED INFUSION AND THE NURSE NOTED THE BAG WAS STILL HALF FULL. THE SET WAS CHANGED AND ANOTHER 40 ML WAS DELIVERED WITH NO ALARMS OR ERRORS. THE PUMP SET WAS NOT SAVED. IT WAS CONFIRMED THAT NO PT HARM OCCURRED. THE ACTUAL PUMP INVOLVED IN THE REPORTED INCIDENT WAS RETURNED FOR EVALUATION. THE VOLUMETRIC ACCURACY WAS TESTED THREE TIMES WITH NO ERRORS OR INTERRUPTIONS. THE RESULTS WERE ALL WITHIN SPECIFICATION: VOLUME TO BE DELIVERED OF 100 ML AT 85 ML/H RATE: 1ST TEST: 85.8 ML IN 1 HOUR AND 00 MINUTE, 2ND TEST: 85.6 ML IN 1 HOUR AND 00 MINUTE, 3RD TEST: 85.9 ML IN 1 HOUR AND 00 MINUTE. THE PUMPS OPERATIONAL LOG WAS REVIEWED. ON 12/17/2012 AT 12:27:13 AM, A STANDARD INFUSION WAS STARTED WITH A RATE OF 100 ML/H FOR A VOLUME OF 85 ML. AT 1:18:14: THE INFUSION COMPLETED WITH A TOTAL VOLUME INFUSED OF 85 ML OR 100% OF THE EXPECTED VOLUME. THE PUMP WENT INTO KVO (KEEP VEIN OPEN) AT A RATE OF 3.0 ML/H AND AT 01:18:14 TO 1:23:43 AM WITH A TOTAL VOLUME INFUSED OF .28 ML AT 97.2% OF THE EXPECTED VOLUME. AT 1:24:38 THE PUMP WAS SET AT TO DELIVER A RATE OF 50 ML/ AT A RATE OF 100 ML/H. AT 1:54:40 THE INFUSION WAS COMPLETED AT A TOTAL VOLUME OF 50 ML DELIVERED OR 100% OF THE EXPECTED VOLUME. THE PUMP WAS NOT OPERATIONAL FOR THE REST OF THAT DAY. BASED ON THE RESULTS OF THIS INVESTIGATION, THE PUMP OPERATED AS INTENDED. NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE EVENT. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER. A FOLLOW UP REPORT WILL BE FILED IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: UNDER INFUSION - 8713050U, SERIAL # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26805 INFUSOMAT SPACE - US VERSION INFUSION PUMP FPA B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other