BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 13952508 · Received March 30, 2022

    Report

    Report Number
    9610825-2022-00111
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    February 12, 2022
    Report Date
    November 20, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    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 MELSUNGEN AG INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). 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. HISTORY FILES WERE INVESTIGATED BY BBM SINGAPORE: "INCIDENT DATE/TIME: (B)(6) 2022, 0948HOURS. MEDICATION: IV ALBUMIN. NURSE REPORTED IV ALBUMIN SHOULD BE COMPLETED BY 1051HOURS BUT NOTED ONLY COMPLETED AT 1110 HOURS. BASED ON THE HISTORY LOGS EXTRACTED FROM (B)(6), THERE WAS NO DISCREPANCY OR ABNORMALITIES FOUND. THE THERAPY WAS COMPLETED AS PER PARAMETERS SET BY NURSE. INFUSION STARTED AT 9.48AM WITH VTBI OF 50ML, RATE AT 50ML/HR AND COMPLETED AT 1050HOURS (TAKEN FROM ORIGINAL HISTORY LOGS). NOTABLE NEW VTBI OF 20ML WAS RESET AT1050HOURS AND COMPLETED AT 1112HOURS AS PER THE PARAMETER SET BY NURSE (TAKEN FROM ORIGINAL HISTORY LOGS)." BBM MELSUNGEN ALSO INVESTIGATED THE HISTORY FILES AND CAN CONFIRM THE INVESTIGATION STATED IN THE COMPLAINT. AT 10:50AM THE VTBI NEAR AND ALARM WAS STILL ON. THE ALARM OCCURRED FIRST TIME AT 10:44AM. AFTER THE ALARM WAS CONFIRMED AT 10:50AM A NEW VTBI VALUE OF 20ML WAS SET BY USER. THE COMPLAINT IS NOT CONFIRMED, BECAUSE THE USER SET A NEW FLOW RATE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "UNDERINFUSION". "INCIDENT DATE/TIME: (B)(6) 2022, 0948HOURS MEDICATION: IV ALBUMIN. NURSE REPORTED IV ALBUMIN SHOULD BE COMPLETED BY 1051HOURS BUT NOTED ONLY COMPLETED AT 1110 HOURS. BASED ON THE HISTORY LOGS EXTRACTED FROM SN (B)(4), THERE WAS NO DISCREPANCY OR ABNORMALITIES FOUND. THE THERAPY WAS COMPLETED AS PER PARAMETERS SET BY NURSE. INFUSION STARTED AT 9.48AM WITH VTBI OF 50ML, RATE AT 50ML/HR AND COMPLETED AT 1050HOURS. NOTABLE NEW VTBI OF 20ML WAS RESET AT1050HOURS AND COMPLETED AT 1112HOURS AS PER THE PARAMETER SET BY NURSE. PHYSICAL USED TUBING WAS NOT AVAILABLE FOR FURTHER INVESTIGATION. AS CONFIRMED WITH NURSE, NO FURTHER COMPLICATION REPORTED AFTER THE EVENT. PATIENT'S CONDITION NOT AFFECTED. FUNCTIONAL TECHNICAL CHECK WAS CARRIED OUT FOR SN (B)(4) WITHIN PRODUCT SPECIFICATION, SERVICE REPORT WAS ISSUED AND ENDORSED BY NUH BME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748322 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown