BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 13951699 · Received March 30, 2022

    Report

    Report Number
    9610825-2022-00106
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    February 11, 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 (B)(4) 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. THE DEVICE WAS NOT AVAILABLE. ONLY THE HISTORY DATA WAS SENT FOR INVESTIGATION. THE DEVICE HISTORY FILES WERE ANALYZED. THE PUMP WAS SWITCHED ON AND A SPACE LINE NEUTRAPUR WAS INSERSTED. THE INFUSION WAS STARTED WITH A RATE OF 14ML/H AND A VOLUME OF 300ML. DURING THE INFUSION THE AIR ALARM COULD BE FOUND, SEVERAL TIMES. AFTER THE AIR ALARMS THE LINE WAS PURGED. AT THE END OF THE INFUSION, THE VOLUME WAS CHANGED TO 30ML AND 10ML. NO OTHER ABNORMALITIES WERE FOUND. THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "OVERINFUSION". "INCIDENT DATE/TIME: 11 FEB, 1546HOURS MEDICATION: IV DOXORUBICIN. NURSE REPORTED THE THERAPY ENDED EARLIER THAN EXPECTED. BASED ON THE EXTRACTED HISTORY LOGS THERE WAS NO DISCREPANCY OR ABNORMALITIES FOUND. THE THERAPY WAS COMPLETED AS PER PARAMETERS SET BY NURSE. IV THERAPY STARTED WITH PARAMETERS OF 300ML VTBI AT RATE OF 14ML/HR. MULTIPLE INSTANCES OF AIR BUBBLE ALARM FOLLOWED BY PURGES. IN THE HISTORY, NOTICED NEW VTBI WAS RESET @ 0757HOURS AND 1745HOURS TO 10ML AND 30ML RESPECTIVELY, BUT RATE UNCHANGED. 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 (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
    2731587 INFUSOMAT SPACE PUMP, INFUSION, FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown