BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2900261 · Received October 19, 2012

    Report

    Report Number
    9610825-2012-00212
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    August 14, 2012
    Report Date
    October 19, 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
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MEDICAL INC IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN (B)(4) (THE MFR) AND (B)(4). THE ACTUAL PUMP INVOLVED IN THE REPORTED INCIDENT WAS RETURNED FOR EVAL. UPON VISUAL EXAMINATION, IT WAS NOTED THAT THE PUMP WAS PHYSICALLY DAMAGED AND NOT OPERABLE WHEN RECEIVED. THE IV SET BEING USED AT THE TIME HAD BEEN REMOVED AND WAS NOT RETURNED WITH THE PUMP. THE PUMP'S DOOR BOLT WAS BENT AND THE DOOR WOULD NOT CLOSE. THE DOOR BOLT, POTENTIOMETER, AND THE DRIVE MOTOR WERE REPLACED TO MAKE THE PUMP OPERABLE. THE VOLUMETRIC ACCURACY OF THE PUMP WAS THEN TESTED THREE TIMES WITH A VOLUME TO BE DELIVERED OF 100.0 ML AT 20.0 ML/H RATE. THE RESULTS WERE ALL WITHIN SPECIFICATION: TEST 1: 101.0 ML IN 5 HOURS AND 00 MINUTES, TEST 2: 102.0 ML IN 5 HOURS AND 00 MINUTES, TEST 3: 101.0 ML IN 5 HOURS AND 00 MINUTES. THE PUMP'S OPERATIONAL LOG WAS REVIEWED. ON (B)(6) 2012 AT 10:58:43 PM A NEW VTBI (VOLUME TO BE INFUSED) OF 100.0 ML WAS ENTERED. AT 10:58:48 PM THE INFUSION WAS STARTED WITH A RATE OF 20.0 ML/H. THE INFUSION CONTINUED INTO THE NEXT DAY, (B)(6) 2012 AND AT 3:58:50 AM THE KVO (KEEP VEIN OPEN) ALARM WAS DISPLAYED AND THE PUMP SWITCHED TO KVO MODE AT RATE OF 5.0 ML/H WITH A TOTAL VOLUME INFUSED OF 100.0 ML OR 100.0% OF THE EXPECTED VOLUME. AT 3:58:54 AM THE PUMP WAS STOPPED. THE INITIAL COMPLAINT REPORT INDICATED THE REPORTED EVENT DATE OCCURRED ON (B)(6) 2012. PER THE OPERATIONAL LOG THE ONLY INFUSION BETWEEN THE TIMES OF 1:37 AND 4:26 DESCRIBED IN THE REPORTED EVENT WAS STARTED ON (B)(6) 2012 AT 10:58:48 PM AND COMPLETED ON (B)(6) 2012 AT 3:58:50 AM WITH 100.0% DELIVERY ACCURACY. IN A FOLLOW UP WITH THE FACILITY, THE REPORTER INDICATED THAT THEY DID NOT TEST THE PUMP BECAUSE THE DOOR WAS NOT ABLE TO BE OPENED. HE ALSO STATED THE DOOR IS NOT RELATED TO THE REPORTED EVENT. NO PT INTERVENTION INVOLVED. 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: (B)(4), SERIAL #(B)(4). PT RECEIVED CONTINUOUS INFUSION OF PANTOPRAZOLE 40MG/100ML NS. RATE SET TO 20 ML/HR VOLUME TO BE INFUSED 100 ML. INFUSION START 1:37, INFUSION END 4:26. TOTAL VOLUME COMPLETED IN 2 HOURS 49 MINUTES DESPITE BEING PROGRAMMED TO RUN OVER 5 HOURS. NO PT INJURY REPORTED.

    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