BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 10851013 · Received November 17, 2020

    Report

    Report Number
    9610825-2020-00308
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    July 30, 2020
    Report Date
    December 1, 2020
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). AS NO SAMPLE WAS PROVIDED, AN EXAMINATION AND ROOT CAUSE ANALYSIS WAS NOT POSSIBLE AT OUR SERVICE LABORATORY IN MELSUNGEN. ACCORDING TO THE ERROR DESCRIPTION NO FURTHER ANALYSES COULD BE PERFORMED. THE INFORMATION PROVIDED HAS BEEN ENTERED INTO OUR COMPLAINT DATABASE AND WILL BE INCLUDED IN OUR TREND ANALYSIS OF THIS PRODUCT LINE. THE COMPLAINT WILL BE ASSESS AS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(6) AG INTERNAL REPORT#: (B)(4). THE DEVICE HAS BEEN REQUESTED TO SEND IT FOR INVESTIGATION TO BBM LABORATORY IN (B)(6). IF AN INVESTIGATION REPORT IS AVAILABLE, A FOLLOW-UP REPORT WILL CREATED. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER, SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "OVER-INFUSION". CUSTOMER INFORMATION: "AT AROUND 1520H, MY MUM CAME TO THE STATION AND SAID THAT THE AQUEOUS PUMP WAS ALARMING, NIC AND I WENT TO THE ROOM AND SAW THAT THE AQUEOUS BAG HAD RAN OUT, AND FLUIDS ONLY REMAINED AT THE LINE. PN STOPPED AT 1526H, WHICH IS HALF AN HOUR EARLIER THAN EXPECTED. TOLD PAEDS TEAM, GASTRO TEAM, GASTRO PHARMACIST, PHARMACIST, PN NURSE SPECIALIST ABOUT IT. BM LEVELS CHECKED AFTER HALF AN HOUR, AND AN HOUR AFTER PN HAS STOPPED 3.4 AND 3.9 MMOL RESPECTIVELY. 10% GLUCOSE IV WAS PUT READY BY BEDSIDE JUST IN CASE BM DROPPED. BM CHECKED AGAIN AT 1800 AND 1830, WHICH WERE BOTH NORMAL 4.2 AND 4.4 MMOL RESPECTIVELY. AQUEOUS PUMP BROUGHT TO CLINICAL ENGINEERING AND A NEW PUMP WAS USED. NEW PN STARTED AT 1830."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316382 INFUSOMAT PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1