BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 2963550 · Received February 1, 2013

    Report

    Report Number
    9610825-2013-00006
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    December 24, 2012
    Report Date
    January 3, 2013
    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
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4). IN A FOLLOW UP CALL TO THE FACILITY, THE REPORTER STATED THAT A 50 ML BAG WAS USED FOR THE INFUSION AND THE PUMP WAS SET TO INFUSE AT A RATE OF 4.5 ML/HR. THE PUMP RAN FOR AN HOUR WHEN THE NURSE SAW THAT THE BAG WAS EMPTY. THE REPORTER CONFIRMED THAT THERE WAS NO PATIENT INJURY. THE ACTUAL PUMP INVOLVED IN THE REPORTED INCIDENT WAS RETURNED FOR EVALUATION. THE PUMP'S VOLUMETRIC ACCURACY WAS TESTED THREE TIMES AND MET SPECIFICATION. VOLUME TO BE DELIVERED OF 4.53ML/HR AND 9.18ML: FIRST TEST: 9.3ML IN 2 HOURS AND 01 MINUTES. SECOND TEST: 9.2ML IN 2 HOURS AND 01 MINUTES. THIRD TEST: 9.3ML IN 2 HOURS AND 01 MINUTES. THE PUMP'S OPERATIONAL LOG WAS REVIEWED. ON (B)(6) 2012 AT 2:59:37 AM, A STANDARD INFUSION WAS STARTED WITH A RATE OF 4.53ML/H. AT 4:45:33 AM, THE INFUSION STOPPED WITH A TOTAL VOLUME INFUSED OF 7.99ML OR 100% OF THE EXPECTED VOLUME. AT 04:46:28, THE PUMP WAS RESTARTED WITH A RATE OF 4.53ML/HR. AT 5:02:16 AM, THE INFUSION WAS STOPPED WITH A TOTAL VOLUME INFUSED OF 1.19ML OR 100% OF THE EXPECTED VOLUME. AT 04:46:28, THE PUMP WAS RESTARTED WITH A RATE OF 4.53ML/HR. AT 5:02:16 AM, THE INFUSION WAS STOPPED WITH A TOTAL VOLUME INFUSED OF 1.19ML OR 100% OF THE EXPECTED VOLUME. AT 5:04:51 AM, THE PUMP WAS TURNED OFF AND NOT USED FOR THE REST OF THE DAY. BASED ON THE RESULTS OF THIS INVESTIGATION, THE PUMP OPERATED AS INTENDED AND THE REPORTED EVENT COULD NOT BE REPRODUCED. NO CONCLUSION CAN BE MADE REGARDING THE CAUSE OF THE EVENT. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE PUMP 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: REF # (B)(4), SERIAL # (B)(4), OCCURRED (B)(6) 2012. REPORTS OVER INFUSION: PUMP SET TO DELIVER 50 MLS OF PRECEDEX (DEXAMID) AT 4.53 ML/HR (0.2 MICROGRAM/KG/HR) AFTER 2 HOURS BAG WAS PRACTICALLY EMPTY. NO PATIENT INJURY OR ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45173 INFUSOMAT SPACE INFUSION PUMP FPA B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other