BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 22047794 · Received May 19, 2025

    Report

    Report Number
    9610825-2025-00274
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    March 25, 2025
    Report Date
    June 2, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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. GENERAL INFORMATION: COMPLAINT: (B)(4). INFORMATION TO THE SAMPLE: MODEL: PERFUSOR SPACE, ARTICLE NUMBER: 8713030, SERIAL NUMBER/BATCH: (B)(6), SOFTWARE VERSION: 688L030003, HOURS OF OPERATION: 11610, FURTHER INFORMATION: N/A. INVESTIGATION RESULTS: HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE CUSTOMER SPECIFIED (B)(6) 2025 AS THE DATE OF THE INCIDENT. ON (B)(6) 2025 15:08 PLUNGER MALFUNCTION ON 73 SEC AFTER START OF INFUSION (B)(6) 2025 15:11 PLUNGER MALFUNCTION ON 75 SEC AFTER SYRINGE CHANGED FURTHERMORE, NO ANOMALIES COULD BE DETECTED INSIDE THE 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 LOWER HOUSING SHELL OF THE P2 PLUG IS MECHANICALLY DAMAGED. NO OTHER VISIBLE DAMAGED PARTS ARE TO LOCATE. THE DEVICE SHOWS AGE RELATED SIGNS OF WEAR AND TEAR. CONTACTS OF THE P2 PLUG ARE ATTACKED BY LIQUID RESIDUE. FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSES THE SELF-TEST. A BBRAUN OMNIFIX 50 ML 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: FOR CHECKING THE COMPLAINT MALFUNCTION THE DEVICE WAS STARTED AND A BBRAUN OMNIFIX 50ML SYRINGE WAS INSERTED 5 TIMES TO SEE IF THE SYRINGE WAS CORRECTLY RECOGNIZED AND GRASPED. NO ERROR COULD BE DETECTED. INDIVIDUAL INSPECTION: A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. HERE A NOMINAL FLOW RATE OF 5 ML/H WAS CHOSEN. THE ASSESSED MEAN DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF +1.08%. ACCURACY OF SET DELIVERY RATE SHOULD BE (B)(4) ACCORDING TO IEC/EN 60601-2-24. DISASSEMBLING: THE DEVICE WAS DISASSEMBLED AND THE INSIDE WAS INVESTIGATED. IT WAS DETERMINED THAT LIQUID RESIDUE CAN BE SEEN ON THE FOIL CONNECTOR (CONNECTION CONTROL UNIT TO BASE CIRCUIT BOARD). THE CLAW MECHANISM IN THE DRIVE HEAD IS MECHANICALLY DAMAGED. JUDGMENT: THE COMPLAINT COULD NOT BE CONFIRMED. A MALFUNCTION OF THE PUMP COULD NOT BE DETECTED. A MALFUNCTION OF THE PUMP COULD NOT BE DETECTED. THERE IS NO INDICATION IN THE DEVICE HISTORY THAT THE PUMP INDEPENDENTLY GAVE A BOLUS. PREREQUISITE FOR THE ALARM "PRESSURE MALFUNCTION" TO OCCUR IS A PERFUSOR THAT HAS GRIPPED THE INSERTED SYRINGE WITH ITS CLAWS. IF NOW THE PLUNGER PLATE OF THE SYRINGE MOVES AWAY FROM THE DRIVE HEAD, THIS IS DETECTED BY A SENSOR IN THE DRIVE HEAD AND THE "PLUNGER MALFUNCTION" ALARM IS TRIGGERED. THE REASON WHY THE PLUNGER PLATE MOVES AWAY FROM THE DRIVE HEAD CANNOT BE DETECTED BY THE PUMP. THIS CAN BE CAUSED FOR EXAMPLE BY MANUAL INTERVENTION OR BY A VERY HIGH NEGATIVE PRESSURE IN THE INFUSION LINE. ADDITION INFORMATION: IT IS RECOMMENDED TO CHANGE THE P2 PLUG, LOWER PART OF THE HOUSING AND THE DRIVE COMPLETE. THE SPINDLE HAS SUFFERED AN IMPACT DUE TO THE DELIVERY ACCURACY MEASUREMENT AND THE DRIVE HEAD IS ALSO MECHANICALLY DAMAGED.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: THE PUMP WAS SER UP FOR 1.5 MILLILITERS (ML) LOADING DOSE, 1.5 MILLILITERS (ML) CONTENTIOUS DOSE LIMIT, BUT DELIVERED 30 MILLILITERS (ML) OF DOSE TO A PATIENT ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166504 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown