BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 15680316 · Received October 27, 2022

    Report

    Report Number
    9610825-2022-00439
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Report Date
    August 4, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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. 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 DEVICE HAS BEEN INVESTIGATED IN OUR SERVICE DEPARTMENT AT B. BRAUN MELSUNGEN AG, MELSUNGEN, GERMANY: 1. GENERAL INFORMATION: COMPLAINT: (B)(4). 2. INFORMATION TO THE SAMPLE: 2.1 MODEL: INFUSOMAT SPACE 2.2 ARTICLE NUMBER: 8713050 2.3 SERIAL NUMBER/BATCH: (B)(4). 2.4 SOFTWARE VERSION: J030006 2.5 HOURS OF OPERATION: 35964 HOURS. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. THE HISTORY FILES AT 2022-09-21 (SPECIFIED DATE OF THE INCIDENT) WERE INVESTIGATED. AT 11:31 AM A SPACE LINE WAS INSERTED. THEN THE VTBI WAS SET TO 295 ML AND THE TIME TO A VALUE OF 02:00 HH:MM. AT 11:32 AM THE INFUSION WAS STARTED. AT 13:35 PM THE INFUSION WAS STOPPED CORRECTLY WITH AN ACT. VOLUME INFUSED OF 295,15 ML. INSIDE THE HISTORY FILES NO ANOMALIES COULD BE DETECTED. 3.2 VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE TECHNICAL SEAL (49-02-260) ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. AT THE HOUSING LOWER PART, LIQUID RESIDUES COULD BE DETECTED. FURTHERMORE, THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGE ARE TO LOCATE. 3.3 FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED 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. 3.4 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. 3.5 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 -1,20%. ((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. 3.6 DISASSEMBLING: DURING THE INVESTIGATION FAULTS COULD BE DETECTED, TO INVESTIGATE THE INSIDE, THE DEVICE WAS DISASSEMBLED COMPLETE. LIQUID RESIDUES INSIDE THE DEVICE COULD BE DETECTED. FURTHERMORE, LIQUID RESIDUES ON THE MAINBOARD COULD BE FOUND. IN ADDITION, THE RIBBON CABLE THAT CONNECTS THE OPERATING UNIT WITH THE MAINBOARD SHOWS PRESSURE POINTS. 4. JUDGMENT: 4.1 THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. NO FLOWRATE DEVIATION COULD BE DETECTED. ADDITION INFORMATION: AN EXCHANGE OF THE DAMAGED PARTS BY LIQUID IS NEEDED. 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 IRELAND: "UNDERINFUSION." ACCORDING TO THE CUSTOMER: "PATIENT ATTENDED DPU FOR THEIR ROUTINE INFLIXIMAB INFUSION. THE MEDICATION WAS CHECKED BY 2 NURSING STAFF-- CORRECT PATIENT, DOSE, CORRECT PRESCRIPTION, EXPIRY DATE, PACKAGING INTACT. THE INFUSION IS GIVEN VIA THE BRAUN PUMP. AGAIN 2 NURSES MUST CHECK THE VOLUME TO BE GIVEN AND THE RATE THIS MUST BE GIVEN AT. IN THIS INCIDENT THE 450MGS OF INFLIXIMAB IN 250MLS OF NORMAL SALINE 0.9% TOTAL VOLUME 295ML WAS GIVEN OVER AN HOUR. THE INFORMATION WAS PUT INTO THE BRAUN PUMP. AFTER 1HOUR APPROXIMATELY HALF THE INFUSION REMAINED IN THE BAG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2481546 INFUSOMAT SPACE PUMP, INFUSION, FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown