BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSOMAT ®

    MDR report key: 18948564 · Received March 21, 2024

    Report

    Report Number
    9610825-2024-00186
    Event Type
    Death
    Date Received
    March 21, 2024
    Date of Event
    November 20, 2023
    Report Date
    June 21, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. 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 · 0

    ACCORDING TO THE CUSTOMER: "BACKGROUND OF THE INCIDENT: INFUSOMAT SPACE PUMP SN (B)(6) (PUMP A ) WAS USED TO RUN IV NORADRENALINE, CONNECTING TO PATIENT'S CVL LINE. FIRST DOSE OF NORADRENALINE WAS INITIATED ON (B)(6) 2023. ON (B)(6) 2023 WHEN STAFF NURSE WANTED TO TOP UP THE MEDICATION, THEY HOOKED UP A NEW BAG OF NORADRENALINE FOR PIGGYBACK PURPOSE ON A NEW INFUSOMAT SPACE PUMP( PUMP B) . WHILE PUMP B WITH NORADRENALINE WAS STARTED, STAFF NURSE SLOWLY TITRATE THE DOSE DOWNWARDS FOR NORADRENALINE WHICH IS RUNNING ON INCIDENT PUMP(PUMP A). AFTER THE COMPLETION OF THE NORADRENALINE ON THE INCIDENT PUMP(PUMP A), STAFF NURSE PROCEED TO STOP THE INFUSION, REMOVE THE INFUSION SET OUT FROM INCIDENT PUMP (PUMP A) WITHOUT CLOSING THE ORANGE ROLLER CLAMP AND WITHOUT DISCONNECTING/CLOSING 3 WAY TAP ON PATIENT'S SITE. AFTER SOME TIME , STAFF NURSE REALIZED THERE WAS A SURGE ON PATIENT'S BP, THEY PROCEEDED TO STOPPED PUMP B TO STABILIZE THE PATIENT AND REPORTED TO THE PHYSICIAN IN CHARGED. THIS WAS WHEN STAFF NURSE REALIZED THAT THE RESIDUAL VOLUME FROM THE DISCONTINUED NORADRENALINE WAS MISSING. THEY SUBSEQUENTLY CHECKED THE INCIDENT DEVICE (PUMP A) , AND REALIZED THAT THE WHITE CLIP ON THE METAL FRONT SHEET WAS BROKEN. THE DEVICE WAS SENT TO BME FOR CHECKS ON (B)(6) 2023. SPARE PART 34521487 WAS REPLACED BY THEIR IN-HOUSE BME ON 5 DEC 23. LAST PM CARRIED ON WAS ON APR 23 ACCORDING TO BME MANAGER , PATIENT PASSED ON (B)(6) 2023, AND WAS RAISED AS A CORONER'S CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755187 INFUSOMAT ® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening