BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT ®

    MDR report key: 19174917 · Received April 24, 2024

    Report

    Report Number
    9610825-2024-00321
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Report Date
    July 8, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER 400650339. 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 INFORMATION: H4 DEVICE MANUFACTURER DATE 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: 24015 H FURTHER INFORMATION: N/A. INVESTIGATION RESULTS: HISTORY INSPECTION: THE HISTORY FILES WERE READ AND SENT TO THE DEVELOPMENT FOR FURTHER INVESTIGATION. THE DEVELOPMENT ANSWERED OUR REQUEST TO INVESTIGATE THE HISTORY AS FOLLOWED: ANALYSIS OF THE HISTORY DATA REGARDING "TIROFIBAN, CATH LAB HIGH DOSE LOAD ADMINISTERED 0.15MG/KG/MIN. FINISHED EARLY." SERIAL NUMBER OF THE DEVICE: (B)(6). ANALYSIS OF THE DEVICE HISTORY DATA: THE DRUG "TIROFIBAN CATH LAB LOAD" WAS SELECTED ONCE IN THE DEVICE HISTORY. WITH THE DRUG "TIROFIBAN CATH LAB LOAD" NO DOSE 0.15MG/KG/MIN WAS ACTIVE. THE DRUG IS DEFINED IN THE DRUG LIBRARY WITHOUT A DOSE UNIT MG/KG/MIN. THE INFUSION STOPPED ONE TIME AT VTBI END, TWO TIMES WITH AN UPSTREAM ALARM AND TWO TIMES IT WAS STOPPED BY THE USER. CONCLUSION: THE HISTORY SHOWS NO ANOMALIES. VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE TECHNICAL SEAL (61-01-041) ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE SHOWS SOME LIQUID RESIDUES. FURTHERMORE, A BROKEN PLASTIC PART OF THE OPERATING UNIT COULD BE DETECTED. IN ADDITION, 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 MECHANICAL PRESSURE WAS SLIGHTLY OUT OF TOLERANCE, BUT IT HAS NO EFFECT ON THE FLOW ACCURACY. FURTHERMORE, THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. 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 +0,39%. ((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 ON THE LOWER HOUSING. JUDGMENT: THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION. THE DAMAGE PARTS ARE DAMAGED BY LIQUID OR IMPACT DAMAGE.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER A PATIENT WAS UNDERGOING INFUSION THERAPY OF TIROFIAN, HIGH DOSE LOAD ADMINISTERED AT 0.15 MILLIGRAMS PER KILOGRAM PER MINUTE (MG/KG/MIN). REPORTEDLY THE INFUSION FINISHED EARLY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947612 INFUSOMAT ® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050 96962245C6

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown