BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFUSOR ®

    MDR report key: 20309682 · Received September 26, 2024

    Report

    Report Number
    9610825-2024-00728
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    August 28, 2024
    Report Date
    September 26, 2024
    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). 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. GENERAL INFORMATION: COMPLAINT: (B)(4) INFORMATION TO THE SAMPLE: MODEL: PERFUSOR SPACE. ARTICLE NUMBER: 8713030. SERIAL NUMBER/BATCH: (B)(6) SOFTWARE VERSION: N030004 HOURS OF OPERATION: 35058. FURTHER INFORMATION: N/A. INVESTIGATION RESULTS: HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE DEVICE HISTORY FILES FROM (B)(6) 2024 WERE INVESTIGATED. IN THE MORNING OF THE (B)(6) 2024 THE INFUSION STOPPED BECAUSE THE SYRINGE HOLDER WAS OPEN. A SYRINGE CHANGE WAS PERFORMED. AFTER 4 MINUTES THE SYRINGE WAS SELECTED. IT COULD BE POSSIBLE, THAT IN THIS TIME THE SYRINGE GOT EMPTY. THE SYRINGE IS ONLY HELD HERE BY THE BLADE OF THE SYRINGE HOLDER. VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE TECHNICIAN SEAL (49-02-1656) ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE SHOWS AGE RELATED SIGNS OF WEAR AND TEAR BUT NO VISIBLE DAMAGE WAS FOUND. 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. INDIVIDUAL INSPECTION: A OPS 50ML SYRINGE WAS INSERTED AND IT COULD BE DETECTED THAT THE BLADE OF THE SYRINGE HOLDER DOES NOT WORK CORRECTLY. THE BLADE DOES NOT APPROACH THE SYRINGE COMPLETELY. A OPS 50ML SYRINGE WAS FILLED WITH WATER AND INSERTED INTO THE PUMP. THE SYRINGE WAS HOLD ONLY BY THE SYRINGE HOLDER. THE PUMP WAS LIFTED APPROX. 1 METER AND AFTER APPROX. 4 MINUTES IT COULD BE OBSERVED THAT THE SYRINGE HAD INFUSED 40ML. THE BLADE OF THE SYRINGE HOLDER, DID NOT HOLD THE PLUNGER OF SYRINGE. DISASSEMBLING: THE DEVICE WAS DISASSEMBLED AND THE INSIDE WAS INVESTIGATED. NO VISIBLE DAMAGE WAS FOUND INSIDE THE DEVICE. JUDGMENT: THE COMPLAINT COULD BE CONFIRMED. DURING THE INVESTIGATION, THE MALFUNCTION COULD BE REPRODUCED. THE BLADE OF THE SYRINGE HOLDER, DID NOT HOLD THE PLUNGER OF THE SYRINGE

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: WHEN CHANGING THE SYRINGE, THE PATIENT (B)(6) 1986, UNINTENTIONALLY INJECTED APPROXIMATELY 40 MILLILITERS OF POTASSIUM INJECTED THROUGH THE DEVICE. AS A RESULT, THE PATIENT REQUIRED RESUSCITATION AND SUFFERED SEVERAL RIB FRACTURES AS A RESULT. THE DEVICE PASSED AN STK TEST IN MAY 2024 PASSED AN STK TEST. AND IS NOT DUE FOR TESTING AGAIN UNTIL 2026 DUE FOR INSPECTION. AN INITIAL EVALUATION OF THE OPERATING CONTROL AND LOGS BY OUR CERTIFIED MEDICAL TECHNICIAN INDICATE THAT THE DEVICE IS IN PERFECT WORKING ORDER, NEVERTHELESS I NEED CONFIRMATION OR A DEFECT REPORT FROM YOU DEFECT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2234971 PERFUSOR ® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713030

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Unknown Required Intervention