BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 24648524 · Received March 20, 2026

    Report

    Report Number
    9610825-2026-00098
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 20, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    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). SAMPLE INFORMATION: PERFUSOR COMPACT, 8714827, SERIAL NO.: (B)(6), SOFTWARE VERSION: PLAA01070. HISTORY INSPECTION: NO DATE OR TIME OF OCCURRENCE IS STORED IN THE DEVICE. ONE INSTANCE OF DEVICE ALARM 22 (UNEXPECTED RESET) WAS IDENTIFIED IN THE SAVED ALARM LOG. VISUAL INSPECTION: THE SEAL ON THE LOWER HOUSING WAS INTACT AND UNDAMAGED. THE DEVICE WAS IN A CLEAN STATE AND NO DAMAGE WAS DETECTED. FUNCTIONAL INSPECTION: THE DEVICE DID START USING THE POWER OF THE BATTERY AND PASSED THE SELF- TEST. TWO BATTERY POWER BARS WERE DISPLAYED BY THE DEVICE. THE MAINS VOLTAGE WAS CONNECTED, WHICH WAS DETECTED BY THE DEVICE. A 50ML ORIGINAL PERFUSOR SYRINGE WAS INSERTED, THE PUMP IDENTIFIED THE SYRINGE, AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP INTO OPERATION. INDIVIDUAL INSPECTION: THE DEVICE WAS LEFT INFUSING FOR 24 HOURS, DURING WHICH NO DEVICE ALARM OCCURRED. CONCLUSION: THE DEFECT COULD BE CONFIRMED. THE ERROR PATTERN COULD BE COMPREHENDED DURING HISTORY ANALYSIS, BUT WAS NOT REPRODUCED DURING THE INVESTIGATION. TO NOTE: OUT OF PRECAUTION, IT IS RECOMMENDED TO REPLACE THE A-MODULE AND BATTERIES. 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, K191910.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: ACCORDING TO THE EVENT DESCRIPTION: DURING PATIENT CARE, THE PATIENT WAS INFUSED WITH NORADRENALINE VIA THE PERFUSOR DESCRIBED ABOVE. AT THE MORNING CHECK, WHICH I PERFORMED MYSELF, THE PERFUSOR SHOWED A FULL BATTERY. BEFORE BEING PUT INTO OPERATION DURING THE MISSION, THE PERFUSOR AGAIN SHOWED A FULL BATTERY. A BRAUN ORIGINAL 50 ML PERFUSOR SYRINGE WITH A BRAUN PERFUSOR LINE WAS USED; IT WAS CONNECTED TO THE PATIENT'S PERIPHERAL ACCESS VIA A THREE WAY STOPCOCK. INITIALLY, A FLOW RATE OF 16 ML/H WAS SELECTED; DURING THE CLINICAL COURSE THE FLOW RATE WAS REPEATEDLY INCREASED AND ULTIMATELY REACHED 99 ML/H. IN ADDITION, MULTIPLE MANUAL BOLUSES WERE ADMINISTERED VIA THE PERFUSOR. DURING TRANSPORT, THE PERFUSOR EMITTED AN AUDIBLE WARNING SIGNAL. A BLINKING BATTERY SYMBOL APPEARED ON THE DISPLAY. A SECOND PERFUSOR WAS THEN PREPARED IN ORDER TO REPLACE IT. WHILE THE SECOND PERFUSOR WAS BEING PREPARED, THE DESCRIBED PERFUSOR SWITCHED ITSELF OFF. IT WAS IMMEDIATELY REACTIVATED AND THEN SHOWED A BATTERY LEVEL OF TWO BARS. THE PERFUSOR WAS THEN DISCONNECTED FROM THE PATIENT AND ANOTHER PERFUSOR WAS USED. APPROXIMATELY ONE MINUTE LATER, THE PERFUSOR SHOWED A FULL BATTERY AGAIN. THE ENTIRE INCIDENT OCCURRED AROUND 17:30. IT CANNOT BE DETERMINED RETROSPECTIVELY WHETHER HARM TO THE PATIENT OCCURRED. HOWEVER, IT DOES NOT SEEM UNREALISTIC THAT, IN A HIGH CATECHOLAMINE DEPENDENT PATIENT POST ROSC, THE SUDDEN FAILURE OF THE ADMINISTERED VASOPRESSOR COULD POTENTIALLY RESULT IN PATIENT HARM. NO IMMEDIATELY CLINICALLY RELEVANT IMPAIRMENT OF THE PATIENT DURING TRANSPORT COULD BE CLEARLY DETERMINED. HOWEVER, DUE TO THE PATIENT'S HIGH CATECHOLAMINE REQUIREMENT IN THE ROSC CONDITION, THERE WAS GENERALLY A RISK OF HEMODYNAMIC INSTABILITY CAUSED BY THE BRIEF INTERRUPTION OF THE NOREPINEPHRINE INFUSION. AFTER SWITCHING ON THE DEVICE, IT INITIALLY DISPLAYED TWO BARS OF BATTERY CAPACITY; ABOUT ONE MINUTE LATER, A FULL BATTERY LEVEL WAS SHOWN AGAIN. THE SYRINGE PUMP WAS REPLACED AS A PRECAUTION WITH A BACKUP DEVICE. NO ADDITIONAL INTERVENTIONS BEYOND STANDARD MONITORING AND ONGOING THERAPY WERE REQUIRED. THE PATIENT'S CURRENT CLINICAL CONDITION IS UNFORTUNATELY UNKNOWN TO US, AS NO FURTHER FEEDBACK WAS RECEIVED AFTER HANDOVER TO THE RECEIVING HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716666 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown