BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 17126328 · Received June 14, 2023

    Report

    Report Number
    9610825-2023-00245
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 11, 2023
    Report Date
    June 20, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    PMA / PMN Number
    K142596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). . THE ACTUAL PUMP INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED TO B. BRAUN'S CARROLLTON, TX FACILITY FOR EVALUATION. LOGS OF THE PUMP WERE PROVIDED AND ISSUE REPORTED WAS NOT CONFIRMED FROM THE LOG REVIEW INVESTIGATION, HOWEVER MULTIPLE REVIEWS WERE PERFORMED AND THE INVESTIGATOR WAS UNABLE TO CONFIRMED THE ISSUE. INVESTIGATION RESULTS: THE REPORTED ISSUE WAS NOT PRESENT DURING INVESTIGATION. - THE REVIEW OF THE LOGS INDICATED THE FOLLOWING: 1) ON 05/10/23 @ 12:53:15 PM THE INITIAL SETUP OF DRUG "HYDR50" FROM DRUG LIBRARY NAME (B)(6). DL WAS SELECTED WITH CARE AREA "PALLIATIVE CARE" ALSO SELECTED. -A DOSE RATE OF 0.5 MG/HR WAS SET (CALCULATED INFUSION RATE OF 0.5 ML/HR) WITH VTBI OF 20ML. 2) AT 12:53:31 PM INFUSION STARTED AT THE SELECTED RATE. 3) AT 7:49:00 PM INFUSION STOPPED WITH 3.45 ML TOTAL VOLUME INFUSED. 4) AT 7:49:11 PM A NEW VTBI OF 96.55ML WAS SET AND INFUSION RESTARTED AT 7:49:13 PM. 5) AT 7:49:20 PM INFUSION STOPPED WITH NO ACTUAL VOLUME INFUSED, AND A NEW VTBI OF 46.55ML WAS SET. INFUSION RESTARTED IMMEDIATELY AND CONTINUED UNTIL 10:54:19 PM WITH 4.99 ML TOTAL VOLUME INFUSED. 6) AT 10:56:35 PM A NEW DOSE RATE OF 1MG/HR WAS SET (CALCULATED RATE OF 1 ML/HR AND INFUSION RESTARTED IMMEDIATELY UNTIL 12:20:44 AM WITH 6.37ML OF TOTAL VOLUME INFUSED. 7) AT 12:20:51 AM A NEW DOSE RATE OF 100MG/HR WAS SET (CALCULATED INFUSION RATE OF 100ML/HR). THE PUMP TRIGGERED A DOSE SOFT LIMIT ALARM(SEE DOSEGRD H. OVERRULES - 61 ALARM ON LINE 3161 OF LOG) WHICH WILL BE DISPLAYED ON THE FRONT SCREEN OF THE PUMP (REFER TO THE FOLLOWING IMAGES OF LOGS AND EXAMPLE OF WARNING ON PUMP DISPLAY). THE ALARM IS DISPLAYED IMMEDIATELY AFTER THE DOSERATE SET AND WAS OVERRIDDEN BY USER. PER THE IFU: THE DRUG LIBRARY ALLOWS BOTH SOFT AND HARD LIMITS TO BE SET. SOFT LIMITS MAY BE OVERRIDDEN OR VALUE RE-PROGRAMMED PER INSTITUTIONAL POLICY. HARD LIMITS MAY NOT BE OVER-RIDDEN. THE SOFT LIMIT SYMBOL APPEARS TO THE LEFT OF THE RUN SCREEN, AS SEEN IN FIGURE BELOW, TO INDICATE WHEN INFUSION IS WITHIN, BELOW OR ABOVE LIMITS. 8) AT 12:20:58 AM INFUSION RESTARTED AFTER OVERRIDING SOFT LIMIT AND STOPPED 12:21:06AM WITH 6.58ML TOTAL VOLUME INFUSED. 9) AT 12:21:17 AM A NEW DOSE RATE SET OF 990MG/HR (INFUSION RATE OF 990ML/HR) WAS SET. AGAIN THE PUMP TRIGGERED A DOSE SOFT LIMIT ALERT (SEE DOSEGRD H. OVERRULES - 62 ALARM ON LINE 3171 OF LOG, SEE LOG IMAGE BELOW) WHICH WOULD HAVE BEEN DISPLAYED ON THE FRONT SCREEN OF THE PUMP. THE ALARM IS DISPLAYED IMMEDIATELY AFTER THE DOSERATE SET AND WAS OVERRIDDEN BY USER. INFUSION THEN RESTARTED ON 12:21:19 AM WITH A RATE OF 990 ML/HR, STOPPING AT 12:27:47 WITH AN ACTUAL VOLUME INFUSED OF 35.93 ML. 10) AT 12:27:57 AM A NEW DOSE RATE SET OF 1001MG/HR (INFUSION RATE OF 1001 ML/HR) WAS SET. AGAIN THE PUMP TRIGGERED A DOSE SOFT LIMIT ALERT (SEE DOSEGRD H.OVERRULES - 63 ALARM ON LINE 3190 OF LOG) WHICH WOULD HAVE BEEN DISPLAYED ON THE FRONT SCREEN OF THE PUMP. THE ALARM IS DISPLAYED IMMEDIATELY AFTER THE DOSERATE SET AND WAS OVERRIDDEN BY USER. INFUSION THEN RESTARTED ON 12:27:58 AM WITH A RATE OF 1001 ML/HR, STOPPING AT 12:28:54 WHEN IT WITH AN ACTUAL VOLUME INFUSED OF 50ML WHEN IT DISPLAYED KVO.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER#:(B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY:WE HAVE A CASE INVOLVING THE B. BRAUN INFUSOMAT PUMP THAT WAS SET TO 990M1/H. TO INFUSE DILAUDID (HYDROMORPHONE) . WE ARE ATTEMPTING TO CONFIRM THAT IT WAS HUMAN INTERACTION, WHICH IS THE DIRECTION THE INVESTIGATION IS HEADED, AS OPPOSED TO PUMP MALFUNCTION. IT THE ATTACHED DATA THE SPECIFIC INFUSION WERE ARE LOOKING AT OCCURRED ON 5/11/2023 BETWEEN 12:21:06 12:23:06. I'M HOPING YOU CAN SAY WITH CERTAINTY WHETHER OR NOT THERE WAS NOTHING WRONG WITH THE PUMP SO WE CAN GO FORWARD WITH THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874211 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 8713051U 97000451D0 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown