BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 21795896 · Received April 8, 2025

    Report

    Report Number
    9610825-2025-00225
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Report Date
    June 12, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K092313, K172831, K191910.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4) PREMARKET SUBMISSION # K092313, K172831, K191910. WE RECEIVED: ONE PERFUSOR SPACE, 8713030, SERIAL NO.: (B)(6), SOFTWARE VERSION 688N030005. THE HISTORY FILES WERE READ OUT AND ANALYZED. CAUSED THAT NO DATE OF OCCURRENCE WAS REPORTED, THE HISTORY LOG FILES OF THE LAST PERFORMED INFUSION THERAPY WERE INVESTIGATED. THE LAST STORED HISTORY LOG FILES WERE FROM (B)(6) 2025. NO ABNORMALITIES WERE FOUND. THE SAMPLE WAS SUBJECTED TO A VISUAL AND FUNCTIONAL EXAMINATION. VISUAL INSPECTION: DURING THE VISUAL INSPECTION OF THE PERFUSOR SPACE, A TECHNICIAN SEAL ON THE LOWER HOUSING AS WELL AS ALL COVER CAPS OF THE SCREW PILLARS WERE AVAILABLE AND UNDAMAGED. THE DEVICE WAS IN A CLEAN STATE AND NO DAMAGES OR SOILING COULD BE FOUND. FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED THE SELF-TEST. A SYRINGE WAS INSERTED. THE PUMP RECOGNIZED AND IDENTIFIED THE SYRINGE TYPE, AND IT WAS POSSIBLE TO SELECT THE SYRINGE TYPE IN THE DISPOSABLE MENU BY USER. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. THE DELIVERY ACCURACY OF THE PUMP WAS CHECKED (RATE 5ML/H). THE DETERMINED VALUE +0,94% WAS WITHIN THE SPECIFICATION (+-2%) (ACCORDING TO EN ISO 60601-2-24). THE DEVICE WAS DISASSEMBLED. NO DAMAGES OR SOILING WERE FOUND. THE DEFECT COULD NOT BE CONFIRMED. NO TECHNICAL MALFUNCTION COULD BE DETECTED DURING THE FUNCTIONAL INVESTIGATION AND ON THE MEASUREMENT OF THE DELIVERY ACCURACY. NO PRODUCT DEVIATION COULD BE IDENTIFIED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: "THE PUMP CAME WITH THE WRONG DESCRIPTION: "PATIENT WITH ONGOING NOREPINEPHRINE GIVES BLOOD PRESSURE 300, GIVES WRONG AMOUNT OF INFUSION? ERROR ON PUMP?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740502 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown