BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 15543046 · Received October 5, 2022

    Report

    Report Number
    9610825-2022-00398
    Event Type
    Malfunction
    Date Received
    October 5, 2022
    Date of Event
    July 29, 2022
    Report Date
    November 21, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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). THE COMPLAINT COULD NOT BE CONFIRMED, BECAUSE NO SAMPLE WAS SENT INTO THE SERVICE REPAIR SHOP IN MELSUNGEN FOR A FURTHER INVESTIGATION PROCESS. ACCORDING TO THE ERROR DESCRIPTION OF THE CUSTOMER NO MORE DETAILED ANALYSIS PROCEDURE COULD BE PERFORMED. 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

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN CHINA: "UNDERINFUSION". ACCORDING TO THE CUSTOMER: "DESCRIPTION OF MALFUNCTION/FAILURE:SET DRIP SPEED DOES NOT MATCH ACTUAL INDICATION:THE PATIENT WAS GIVEN HIGH-DOSE METHOTREXATE CHEMOTHERAPY, AND INFUSION PUMP WAS USED TO CONTROL THE INFUSION RATE AND DOSE. IT WAS REQUIRED TO SUCCESSFULLY COMPLETE THE INFUSION WITHIN THE SPECIFIED TIME TO ENSURE SAFE USE. DESCRIPTION OF EVENT:THE PATIENT WAS TREATED WITH LYMPHOMA CHEMOTHERAPY. ON (B)(6) 2022, THE NURSE INFUSED 5% GLUCOSE 500 ML + METHOTREXATE 6.1 G CHEMOTHERAPEUTIC DRUGS VIA INFUSION PUMP IN THE WARD, SET AS 100 ML/H, AND EXPECTED TO COMPLETE THE INFUSION WITHIN 5 HOURS. RESULTS: THE INFUSION FLUID WAS 420 ML IN 5 HOURS, WHICH WAS NOT COMPLETED ON TIME. THE INFUSION RATE WAS ADJUSTED AGAIN, AND CLOSE ATTENTION WAS PAID TO THE INFUSION RATE. AFTER SET AS 120 ML/H, NO SUCH EVENT OCCURRED. COMBINED USE OF MEDICATION/DEVICE: MATCHING DISPOSABLE LIGHT-RESISTANT PRECISION INFUSION SET (JIANGXI SANXIN MEDICAL TECHNOLOGY CO., LTD.), 5% GLUCOSE 500ML + METHOTREXATE 6.1 G CHEMOTHERAPEUTIC DRUGS. DESCRIPTION OF ROOT CAUSE ANALYSIS (BY REPORTER):PRODUCT QUALITY FACTORS, PRODUCT AGING FACTORS, OTHER FACTORS PRELIMINARY HANDLING OF EVENT: IT WAS FOUND THAT THE INFUSION WAS NOT COMPLETED ACCORDING TO THE SCHEDULED TIME, THE INFUSION RATE WAS RE-ADJUSTED, AND THE INFUSION RATE WAS CLOSELY MONITORED. NO SUCH EVENT OCCURRED AFTER SETTING THE 120 ML/H."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419579 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization