BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT ®

    MDR report key: 19725446 · Received July 11, 2024

    Report

    Report Number
    9610825-2024-00566
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    May 31, 2024
    Report Date
    October 7, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (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. GENERAL INFORMATION: COMPLAINT: (B)(4). ---------------------------------------------------------------- INFORMATION TO THE SAMPLE: MODEL: INFUSOMAT SPACE ARTICLE NUMBER: 8713050 SERIAL NUMBER/BATCH: (B)(6). SOFTWARE VERSION: N030005 HOURS OF OPERATION: 19534 FURTHER INFORMATION: N/A ---------------------------------------------------------------- INVESTIGATION RESULTS: HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE DEVICE HISTORY FILES FROM 2024-06-28 WERE INVESTIGATED. A SPACE LINE WAS SELECTED AND THE INFUSION STARTED WITH A RATE 100ML/H AND A VOLUME OF 1000ML. DIRECTLY AFTER START THE INFUSION, THE UPSTREAM ALARM OCCURRED BECAUSE THE ROLLER CLAMP WAS CLOSED. THE INFUSION WAS CONTINUED AND THE PRESSURE ALARM OCCURRED, TWO TIMES. THE INFUSION WAS STOPPED, AT THIS TIME 429 ,55ML WAS INFUSED. THE LINE WAS EXTRACTED. NO OTHER ABNORMALITIES WERE FOUND. VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE PRODUCTION SEAL ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGE ARE TO LOCATE. FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSES THE SELF-TEST. A SPACE LINE WAS INSERTED, AND THE PUMP IDENTIFIED THE LINE, AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. PRESSURE INSPECTION: IN CHECKING THE DOWNSTREAM-SENSOR THE ELECTRONIC PRESSURE CUT-OFF AND THE MECHANICAL PRESSURE LIMITATION OF THE DEVICE WERE TESTED, ACCORDING TO THE REQUIREMENTS OF THE TECHNICAL SAFETY CHECK. THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. FLOW RATE INSPECTION: A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. HERE A NOMINAL FLOW RATE OF 100 ML/H WAS CHOSEN. THE ASSESSED AVERAGE DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF -0,17%. ((ACCURACY OF SET DELIVERY RATE SHOULD BE: ± 5 % ACCORDING TO IEC/EN 60601-2-24) THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. DISASSEMBLING: THE DEVICE WAS DISASSEMBLED AND THE INSIDE WAS INVESTIGATED. INSIDE THE DEVICE COULD BE FOUND LIQUID RESIDUES ON THE EMC PROTECTION SHIELD AND THE LOWER HOUSING. --------------------------------------------------------------- JUDGMENT: THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (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. CORRECTION: H11: THE INVESTIGATION DETAILED IN THE INITIAL MDR REPORT ANALYZED LOG FILES FROM THE INCORRECT DATE OF JUNE 28, 2024. THIS FOLLOW-UP REPORT IS PROVIDED TO CORRECT THE INVESTIGATION BY ANALYZING THE LOG FILES FROM THE CORRECT DATE, MAY 31, 2024. GENERAL INFORMATION: COMPLAINT: (B)(4). INFORMATION TO THE SAMPLE: MODEL: INFUSOMAT SPACE; ARTICLE NUMBER: 8713050; SERIAL NUMBER/BATCH: (B)(6), SOFTWARE VERSION: N030005; HOURS OF OPERATION: 19534; FURTHER INFORMATION: N/A. INVESTIGATION RESULTS: HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE DEVICE HISTORY FILES FROM 2024-05-31 WERE INVESTIGATED. A SPACE LINE WAS INSERTED AND THE INFUSION STARTED WITH A RATE OF 100ML/H AND VOLUME OF 1000ML AT 01:33AM. THE UPSTREAM ALARM OCCURRED, BECAUSE THE ROLLER CLAMP WAS CLOSED. THE INFUSION WAS CONTINUED. DURING THE INFUSION, THE PRESSURE ALARM OCCURRED TWO TIMES. THE REASON FOR THE ALARM COULD NOT BE CLARIFIED. THE INFUSION WAS CONTINUED AND STOPPED AT 05:58AM. IT WAS STARTED A FEW MORE TIMES BUT STOPPED AT 06:05AM AT THIS TIME, 429,55ML WAS INFUSED. NO OTHER ABNORMALITIES WERE FOUND. VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE PRODUCTION SEAL ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGE ARE TO LOCATE. FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSES THE SELF-TEST. A SPACE LINE WAS INSERTED, AND THE PUMP IDENTIFIED THE LINE, AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. PRESSURE INSPECTION: IN CHECKING THE DOWNSTREAM-SENSOR THE ELECTRONIC PRESSURE CUT-OFF AND THE MECHANICAL PRESSURE LIMITATION OF THE DEVICE WERE TESTED, ACCORDING TO THE REQUIREMENTS OF THE TECHNICAL SAFETY CHECK. THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. FLOW RATE INSPECTION: A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. HERE A NOMINAL FLOW RATE OF 100 ML/H WAS CHOSEN. THE ASSESSED AVERAGE DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF -0,17%. ((ACCURACY OF SET DELIVERY RATE SHOULD BE: ± 5 % ACCORDING TO IEC/EN 60601-2-24) THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. DISASSEMBLING: THE DEVICE WAS DISASSEMBLED AND THE INSIDE WAS INVESTIGATED. INSIDE THE DEVICE COULD BE FOUND LIQUID RESIDUES ON THE EMC PROTECTION SHIELD AND THE LOWER HOUSING. JUDGMENT: THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: MALFUNCTIONING BRAUN INFUSOMAT SPACE THAT DID NOT INFUSE FLUIDS/MEDICATIONS AS IT SHOULD HAVE. TIME OF INCIDENT: 05:00 - 05:59 DESCRIPTION OF INCIDENT: THE BRAUN INFUSOMAT SPACE (TAG NUMBER 1002902) WAS SET TO INFUSE 100MLS PER HOUR OF DEXTROSE 5% 1 LITRE WITH 40 MMOLS KCL. AFTER A FEW HOURS IT WAS NOTICED THAT THE BAG STILL LOOKED FULL WHEN IT SHOULD HAVE INFUSED 430 MLS (ON THE SCREEN VTBI = 570.4MLS). THE BLOOD RESULTS ALSO REFLECT THAT THE FLUID MAY NOT BEEN INFUSED TO THE PATIENT EG POTASSIUM LEVEL NOT IMPROVING AND SODIUM LEVEL RISING. IV CANNULA WORKING, THE PUMP DID NOT ALARM AT ANY STAGE. ADDITIONAL INFORMATION FROM CLINICAL NURSE MANAGER 3, CRITICAL CARE, HDU: AS FAR AS I AM AWARE THE PATIENT DID NOT RECEIVE THE IV FLUIDS AS PRESCRIBED IN THE TIME SPECIFIED SO IT BECOMES A MEDICATION ERROR. THE TREATMENT REQUIRED WAS IV FLUIDS WHICH WERE DELAYED AS A RESULT OF THE MALFUNCTION. THE IV FLUIDS WERE THEN INFUSED VIA A DIFFERENT PUMP AT THE PRESCRIBED RATE. THERE WERE NO LONG TERM EFFECTS TO THE PATIENT KNOWN AS A RESULT OF THE INCIDENT. HOWEVER, I AM NOT THE OWNER OF THE INCIDENT SO CANNOT TRACK IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346774 INFUSOMAT ® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female