BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT ®

    MDR report key: 18369395 · Received December 20, 2023

    Report

    Report Number
    9610825-2023-00598
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 17, 2023
    Report Date
    March 14, 2024
    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 MEDICAL INTERNAL REPORT NUMBER (B)(4). 1. GENERAL INFORMATION: COMPLAINT: (B)(4). 2. INFORMATION TO THE SAMPLE: 2.1 MODEL: INFUSOMAT FMS. 2.2 ARTICLE NUMBER: 8715440. 2.3 SERIAL NUMBER/BATCH: (B)(6). 2.4 SOFTWARE VERSION: IFME03007. 2.5 HOURS OF OPERATION: 32566. 2.6 SEAL: YES (49-02-260). 2.7 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: N/A. 3.2 VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS AND THE SEAL ON THE BACK HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE WAS DELIVERED IN A CLEAN STATE. THE CABLE OF THE DROP SENSOR WAS DAMAGED AND THE MEMBRANE WAS SHOWING AGE RELATED SIGNS OF WEAR. 3.3 FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE DID START USING THE POWER OF THE BATTERY PACK AND PASSED THE SELF-TEST, THE MAINS VOLTAGE WAS CONNECTED, AND THE BATTERY PACK GOT CHARGED. AN INFUSOMAT SPACE LINE WAS INSERTED, AND IT WAS POSSIBLE TO PUT THE PUMP INTO OPERATION. DROPS WERE RECOGNIZED BY THE CONNECTED DROP SENSOR. 3.4 INDIVIDUAL INSPECTION: 3.4.1 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 MEAN DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF +0,86%. 3.5 DISASSEMBLING: DURING DISASSEMBLY, IT WAS FOUND THAT THE STEPPER MOTOR HAD A LARGER BEARING CLEARANCE THAN USUAL. 3.6 TEST EQUIPMENT: DESCRIPTION: N/A. TYP NR.: N/A. LAB.-ID.-NR. N/A. 3.7 FOR EXAMINATION USED DISPOSABLES: DESCRIPTION: N/A REF.: N/A LOT: N/A 4. JUDGMENT: 4.1 THE COMPLAINT COULD NOT BE CONFIRMED. THE DESCRIBED ERROR PATTERN COULD NOT BE REPRODUCED. THE MEASURED FLOW RATE WAS WITHIN THE SPECIFICATION. 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 INTERNAL REPORT NUMBER (B)(4). 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN IRELAND: "UNDER INFUSION" ACCORDING TO THE COMPLAINANT, THE PUMP INFUSED 1078.9 MILLILITERS (ML) OF 1198 ML; 119.1 ML WERE NOT INFUSED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. INFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289457 INFUSOMAT ® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8715440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown