BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSOMAT®

    MDR report key: 17754408 · Received September 15, 2023

    Report

    Report Number
    9610825-2023-00431
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    July 15, 2023
    Report Date
    October 25, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. B. BRAUN MEDICAL INC. RECEIVED AN EMAIL WITH AN ATTACHMENT OF ISSUES ENCOUNTERED IN THE CUSTOMERS INTENSIVE CARE UNIT BETWEEN 15JUL2023 - 17JUL2023 WHEN USING THE B. BRAUN INFUSION PUMPS AND ACCESSORIES. THE ATTACHMENT LISTED MULTIPLE EVENTS OF AIR-IN-LINE ALARMS, MICROBUBBLES IN IV LINES, REPORTS OF CHANGED LINES, AND IV LINES THAT MAY HAVE BEEN KINKED, BROKEN OR SHORT. THIS REPORT IS BEING SUBMITTED FOR THE LINE THAT INDICATES THE FOLLOWING EVENT; "PT. CRASHING, ALARMS REPEATED." WITH THE USE OF A B. BRAUN INFUSION PUMP. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). REPORTED ISSUE COULD NOT BE CONFIRMED DUE TO NO SAMPLE RETURNED FOR FURTHER INVESTICATION. ALTHOUGH A SAMPLE WAS NOT RECEIVED AT THE TIME OF THE COMPLAINT ISSUANCE, B.BRAUN HAS IDENTIFIED A SPORADIC OCCURRENCE OF POTENTIALLY FALSE DOWN- AND UPSTREAM PRESSURE ALARMS WHICH ARE CAUSED BY THE UPSTREAM OCCLUSION PRESSURE SENSOR OF THE INFUSOMAT® INFUSION PUMP. OUR INVESTIGATIONS HAVE SHOWN THAT AN ISOLATED BATCH OF UPSTREAM OCCLUSION SENSORS BUILT IN THE FOLLOWING SERIAL NUMBERS OF PUMPS MAY DEVIATE FROM THEIR TECHNICAL SPECIFICATION. FIELD CORRECTIVE ACTION FCSA-2023-08-14 HAS BEEN ISSUED BY THE SUPPLIER (B.BRAUN MELSUNGEN) TO ADDRESS THIS EVENT.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: OUR B BRAUN TEAM RECEIVED AN EMAIL FROM CUSTOMER WITH ATTACHMENT OF NEW REPORTS OF ISSUES ENCOUNTERED IN THE INTENSIVE CARE UNIT BETWEEN 15JUL2023 - 17JUL2023 WHEN USING THE B. BRAUN INFUSION PUMPS AND ACCESSORIES. THE ATTACHMENT LISTED MULTIPLE EVENTS OF AIR-IN-LINE ALARMS, MICROBUBBLES IN IV LINES, REPORTS OF CHANGED LINES, AND IV LINES THAT MAY HAVE BEEN KINKED, BROKEN OR SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294525 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other