BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 22770231 · Received August 11, 2025

    Report

    Report Number
    9610825-2025-00493
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 15, 2025
    Report Date
    January 23, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME 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. 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 MEDICAL INTERNAL REPORT NUMBER (B)(4). THE HISTORY FILES WERE READ OUT AND ANALYZED. THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE CUSTOMER SPECIFIES (B)(6) 2025 AS THE DATE OF THE INCIDENT. ACCORDING TO THE CUSTOMER THE TIME AND DATE ON THE DEVICE HAD AN OFFSET OF 1 HOUR, 23 MINUTES AND 45 SECONDS AHEAD OF BRITISH SUMMER TIME. THIS MUST BE CONSIDERED WHEN INTERPRETING THE LOG FILES. ON (B)(6) 2025 AT 12:04 (LOGFILE TIME) A BD PLASTIPAK 50ML SYRINGE WAS SELECTED. THE SYRINGE WAS FILLED TO APPROX. 49ML. THE THERAPY WAS INTERRUPTED BY THE USER WITH A NEW THERAPY AT 19:29. 39,5ML WERE INFUSED IN TOTAL. NO ABNORMALITIES CAN BE FOUND IN THE DEVICE HISTORY FILES. THE SAMPLE WAS SUBJECTED TO A VISUAL AND FUNCTIONAL EXAMINATION. VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS AND THE PRODUCTION SEAL ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE SHOWS AGE RELATED SIGNS OF WEAR AND TEAR. NO EXTERNAL DAMAGE IS VISIBLE. FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSES THE SELF-TEST. A BD PLASTIPAK 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 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 +0.40%. THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. THE DEVICE WAS DISASSEMBLED AND THE INSIDE WAS INVESTIGATED. NO VISIBLE DAMAGE INSIDE THE DEVICE COULD BE FOUND. THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE PERFUSOR SPACE OPERATED WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: "PCA HAD BEEN SET FOR A BOLUS DOSE OF 1.5MG/ML THROUGHOUT THE COURSE OF THE SHIFT, WITH A PLAN IN PLACE WITH PATIENT, DR, NIC AND NURSE CARING FOR PATIENT TO REDUCE THIS TO 1MG/ML AT 19:00. WHEN NIC AND NURSE CARING FOR PATIENT ARRIVED TO PATIENT AT 19:15 TO ADJUST THE DOSE TO 1MG/ML, WE FOUND THE BOLUS DOSE WAS SET AT 3MG/ML. THERE WAS ALSO MICROPORE TAPE AROUND THE PLASTIC CASING OF THE PCA DEVICE TO THE RIGHT SIDE OF PUMP (NOT PLACED THERE BY ANY NURSING, MEDICAL TEAM OR CSW'S). "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2109387 PERFUSOR® PUMP, INFUSION, PCA MEA B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown