BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2900236 · Received November 19, 2012

    Report

    Report Number
    9610825-2012-00240
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    October 21, 2012
    Report Date
    November 16, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 IS SUBMITTING A SINGLE REPORT ON BEHALF OF B BRAUN (B)(4) (THE MFR), AND (B)(4) (THE IMPORTER). THE VOLUMETRIC ACCURACY WAS TESTED: TEST 1 = 25.0 ML IN 6 MINUTES AND 0 SECONDS; TEST 2 = 6.90 ML IN 1 HOUR 56 MINUTES; TEST 3 = 1.89 ML IN 1 HOUR AND 4 MINUTES; TEST 1 PERFORMED WITH A VTBD: 25.0 ML @ 250 ML/H RATE. TEST 2 PERFORMED WITH A VTBD: 6.88 ML @ 3.54 ML/H RATE. TEST 3 PERFORMED WITH A VTBD: 1.88 ML @ 1.77 ML/H RATE. THE VOLUMETRIC ACCURACY WAS WITHIN SPEC. THE PUMP'S OPERATION LOG WAS REVIEWED. ON (B)(6) 2012 AT 7:10:25 PM A STANDARD INFUSION WAS STARTED WITH A RATE OF 3.54 ML/H. AT 9:07:01 PM THE INFUSION WAS STOPPED WITH A TOTAL VOLUME INFUSED OF 6.88 ML OR 100 % OF THE EXPECTED VOLUME. AT 9:07:07 PM A "NEW DOSE RATE SET; 1.000; MICROGRAM/KGKG/HOUR" AND A "NEW RATE SET; 1.77; ML/H" WAS ENTERED. AT 9:07:09 PM THE INFUSION WAS STARTED WITH THE RATE OF 1.77 ML/H. AT 10:10:58 PM THE INFUSION WAS STOPPED WITH A TOTAL VOLUME INFUSED OF 1.88 ML OR 100% OF THE EXPECTED VOLUME. AT 10:11:08 PM A "NEW DOSE RATE SET; 0.497 MICROGRAM/KGKG/HOUR" AND A "NEW RATE SET; 0.88 ML/H" WERE ADOPTED OR ENTERED. AT 10:11:12 PM THE INFUSION WAS STARTED WITH THE RATE OF 0.88 ML. AT 10:12:00 PM THE INFUSION WAS STOPPED WITH A TOTAL VOLUME INFUSED OF 0.01 ML OR 100 % OF THE EXPECTED VOLUME. AT 10:12:57 PM THE PUMP WAS PLACED ON "STANDBY." AT 10:15:04 PM THE PUMP WAS TAKEN OUT OF "STANDBY," THIS PATTERN WAS REPEATED SEVERAL MORE TIMES. AND, AT 10:58:01 PM THE PUMP WAS POWERED OFF FOR THE DAY. PER OPERATIONAL LOG THERE IS NO INDICATION THE PUMP CHANGED RATES ON ITS OWN. THERE WERE THREE INFUSIONS WITH THE RATES OF 3.54 ML/H, 1.77 ML/H AND 0.88 ML/H THAT RAN BETWEEN THE TIMES OF 7:10:25 PM AND 10:12:00 PM, EACH TIME THE PUMP WAS MANUALLY STOPPED AND THE RATE CHANGED MANUALLY. PER THE LOG THE PUMP OPERATED AS PROGRAMMED AND WITHIN SPEC. THE DELIVERY ACCURACY FOR ALL 3 INFUSIONS WAS 100 % EACH TIME. BASED ON THE RESULTS OF THIS INVESTIGATION, THE PUMP OPERATED AS INTENDED AND NO SPECIFIC CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: THE PUMP WAS INFUSING FENTANYL. THE PUMP WAS SET TO DIFFERENT RATES LISTED BELOW. VOLUME 40 MIL OF FENTANYL. SET AT 3.54 PER HOUR; DECREASED TWO HOURS LATER TO 1.77 MILL PER HOUR; DECREASED AT 10:11 PM TO .088 PER HOUR. NURSE NOTICED BAG EMPTY AT THIS TIME AND TURNED OFF PUMP.

    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