BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFUSOR®

    MDR report key: 22047798 · Received May 19, 2025

    Report

    Report Number
    9610825-2025-00278
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    April 23, 2025
    Report Date
    May 19, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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). 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. GENERAL INFORMATION: COMPLAINT: (B)(4). INFORMATION TO THE SAMPLE: MODEL: PERFUSOR SPACE. ARTICLE NUMBER: 8713030. SERIAL NUMBER/BATCH: (B)(6). SOFTWARE VERSION: 688M030003. HOURS OF OPERATION: 37886. FURTHER INFORMATION: N/A. INVESTIGATION RESULTS: HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE CUSTOMER SPECIFIED 2025-04-23 AS THE DATE OF THE INCIDENT. DURING THIS DAY ACCORDING TO THE DEVICE HISTORY, IT CAN ONLY BE DETERMINED THAT THE PUMP HAS BEEN SWITCHED OFF TWICE BY THE USER. ONCE AT 3:01PM AND ONCE AT 4:20PM. NO ABNORMALITIES CAN BE FOUND IN THE DEVICE HISTORY FILES. VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE TECHNICIAN SEAL ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE SHOWS AGE RELATED SIGNS OF WEAR AND TEAR. WHEN YOU PICK UP THE PUMP, YOU CAN HEAR LOOSE PARTS INSIDE THE APPLIANCE. FROM THE OUTSIDE NO VISIBLE DAMAGE ARE TO LOCATE. FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSES THE SELF TEST. A OPS 50ML SYRINGE WAS INSERTED, AND THE PUMP IDENTIFIED THE SYRINGE AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. DURING THE FUNCTIONAL TEST, A LOOSE CONTACT WAS FOUND ON THE P2 PLUG AND THE SYRINGE HANDLE DOES NOT STAY OPEN ENOUGH TO INSERT A SYRINGE WITHOUT HELP. THE ERROR IN COMPLAINT COULD NOT BE REPRODUCED DURING THE FUNCTION CHECK. DISASSEMBLING: THE DEVICE WAS DISASSEMBLED AND THE INSIDE WAS INVESTIGATED. THE CAUSE OF THE LOOSE PARTS INSIDE THE DEVICE WAS LOCALIZED IMMEDIATELY. THE DRIVE GUIDE ROD IS LOOSE. THE CLAW MECHANISM IN THE DRIVE HEAD IS ALSO MECHANICALLY DAMAGED. WHEN DISMANTLING THE OPERATING UNIT, IT WAS FOUND THAT THE PROTECTIVE FILM WAS STILL STUCK TO THE LCD DISPLAY. JUDGMENT: THE COMPLAINT COULD NOT BE CONFIRMED. DURING THE DAY OF INCIDENT ACCORDING TO THE DEVICE HISTORY, IT CAN ONLY BE DETERMINED THAT THE PUMP HAS BEEN SWITCHED OFF TWICE BY THE USER. ONCE AT 3:01PM AND ONCE AT 4:20PM. THE ERROR IN COMPLAINT COULD NOT BE REPRODUCED DURING THE FUNCTION CHECK. DURING DISMANTLING, THE PUMP WAS FOUND TO HAVE BEEN DAMAGED BY A FALL. LOOSE PARTS INSIDE THE PUMP COULD BE HEARD FROM THE OUTSIDE. A GUIDE ROD FROM THE DRIVE IS LOOSE. ADDITION INFORMATION: IT IS RECOMMENDED TO REPLACE THE COMPLETE DRIVE, SYRINGE HOLDER, P2 PLUG AND LOWER HOUSING SHELL.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: THE PERFUSOR STOPPED DURING OPERATION. IT WAS NOTICED DUE TO THE PATIENT'S BLOOD PRESSURE DROP. NO PATIENT IMPAIRMENT OCCURRED DUE TO THE QUICK INTERVENTION OF THE STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166508 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713030G 5055125110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention