BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERFUSOR®

    MDR report key: 17646207 · Received August 29, 2023

    Report

    Report Number
    9610825-2023-00403
    Event Type
    Death
    Date Received
    August 29, 2023
    Date of Event
    July 28, 2023
    Report Date
    August 29, 2023
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. STOPPED INFUSION: 1. GENERAL INFORMATION: COMPLAINT: (B)(4). EXAMINATION CARRIED OUT BY: (B)(4). 2. INFORMATION TO THE SAMPLE: 2.1 MODEL: PERFUSOR SPACE. 2.2 ARTICLE NUMBER: 8713030. 2.3 SERIAL NUMBER/BATCH: (B)(6). 2.4 SOFTWARE VERSION: N030005. 2.5 HOURS OF OPERATION: 6631 H. 2.6 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE HISTORY FILES FROM (B)(6) 2023, (SPECIFIED DATE OF THE INCIDENT, GIVEN FROM THE COSTUMER) WERE INVESTIGATED. AT 14:28 PM A BD PLASTIPAK 50 ML SYRINGE WAS INSERTED. IN THE SAME MINUTE SEVERAL VALUES WERE SET BY THE COSTUMER: NEW PATIENT WEIGT:70 KG, NEW AMOUNT SET: 2 MG, NEW VOLUME 50 ML, RATE:42 ML, TOM STATE 2 (SLAVE). AT 15:28 PM THE INFUSION WAS STARTED CAUSED BY THE TOM FUNCTION (MASTER PUMP RAN EMPTY) WITH A RATE OF 42 ML/H. THEREFORE, THE TOM FUNCTION WAS DEACTIVATED, BECAUSE THE FIRST PUMP (MASTER) FINISHED THE INFUSION. AT 15:56 PM A NEW DOSE RATE OF 0,1 MICROGRAM/KG/MINUTE WAS SET. THEREFORE, THE RATE WAS CHANGED TO 10,5 ML/H DURING THE INFUSION. IN THE SAME MINUTE THE COSTUMER PRESSED THE START/STOP BUTTON ON THE KEYBOARD AND STOPPED THE INFUSION. FURTHERMORE, THE DEVICE WAS SET INTO STANDBY MODE BY PRESSING THE ON/OFF BUTTON ON THE KEYBOARD. AT 18:13 PM THE STANDBY MODE WAS DEACTIVATED, AND THE SYRINGE WAS TAKEN OUT. IN ADDITION, NO MORE ANOMALIES COULD BE DETECTED INSIDE THE HISTORY FILES. (HISTORY FILES ARE ATTACHED TO THE PC NOTIFICATION). 3.2 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. BETWEEN THE GAPS (UPPER HOUSING PART AND LOWER HOUSING PART) LIQUID RESIDUES COULD BE DETECTED. FURTHERMORE, THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGE ARE TO LOCATE. (PICTURES ARE ATTACHED TO THE PC NOTIFICATION). 3.3 FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSES THE SELF-TEST. A BD PLASTIPAK 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. 3.4 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 +0,58%. ACCURACY OF SET DELIVERY RATE SHOULD BE ± 2 % ACCORDING TO IEC/EN 60601-2-24. 3.5 DISASSEMBLING: DURING THE INVESTIGATION FAULTS COULD BE DETECTED, TO INVESTIGATE THE INSIDE, THE DEVICE WAS DISASSEMBLED COMPLETE. INSIDE THE OPERATING UNIT OXIDIZED CONTACTS COULD BE DETECTED. IT CANNOT BE RULED OUT THAT THE OXIDIZED CONTACTS PRODUCED A MALFUNCTION AT THE DISPLAY. FURTHERMORE, NO DAMAGE ORE SOILING COULD BE DETECTED INSIDE THE DEVICE. (PICTURES ARE ATTACHED TO PC-NOTIFICATION). 3.6 TEST EQUIPMENT: DESCRIPTION: TYP NR.: LAB.-ID.-NR. N/A . 3.7 FOR EXAMINATION USED DISPOSABLES: DESCRIPTION: BD PLASTIPAK 50 ML. REF: (B)(6). LOT:2204097. 4. JUDGMENT: 4.1 THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE PERFUSOR SPACE OPERATED WITHIN OUR SPECIFICATION. NO FLOWRATE DEVIATION COULD BE REPRODUCED. INSIDE THE HISTORY FILES IT COULD BE DETECTED THAT THE VALUES WERE CHANGED, AND THE INFUSION WAS STOPPED: "AT 15:56 PM A NEW DOSE RATE OF 0,1 MICROGRAM/KG/MINUTE WAS SET. THEREFORE, THE RATE WAS CHANGED TO 10,5 ML/H DURING THE INFUSION. IN THE SAME MINUTE THE COSTUMER PRESSED THE START/STOP BUTTON ON THE KEYBOARD AND STOPPED THE INFUSION. FURTHERMORE, THE DEVICE WAS SET INTO STANDBY MODE BY PRESSING THE ON/OFF BUTTON ON THE KEYBOARD. FURTHERMORE, NO ANOMALIES COULD BE DETECTED INSIDE THE HISTORY FILES. ADDITION INFORMATION: DURING THE DISASSEMBLING OXIDIZED CONTACTS INSIDE THE OPERATING UNIT COULD BE DETECTED. DURING THE INVESTIGATION THE OPERATING UNIT WORKS AS SPECIFICATION AND NO ANOMALIES COULD BE DETECTED. IT CANNOT BE RULED OUT THAT THE OXIDIZED CONTACTS PRODUCED THE COMPLAINT MALFUNCTION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: "DYSFUNCTION -DEATH." ACCORDING TO THE CUSTOMER: "THE SYRINGE PUMP STOPPED DURING THE INFUSION (NORADRENALINE). THE TREATMENT COULD NOT BE ADMINISTERED, WHICH ACCELERATED THE DEATH OF THE PATIENT (PATIENT AT THE END OF LIFE). INCIDENT ON (B)(6) 2023. BETWEEN 3 P.M. AND 4:45 P.M. THE CUSTOMER WILL RETURN 6 DEVICES TO US FOR INSPECTION BECAUSE SHE DOES NOT KNOW WITH WHICH THE INCIDENT OCCURRED. FURTHER INFORMATION: WE COULD NOT TO CLEARLY IDENTIFY THE MALFUNCTIONING UNIT, BUT IT WOULD CERTAINLY HAVE BEEN 634943, WHICH PAUSED AT 3.28PM, OR (B)(6), WHICH PAUSED AT 3.56PM. WE COULD NOT IDENTIFY THE CAUSE OF THIS MALFUNCTION. WE DO NOT KNOW WHETHER AN ALARM WAS TRIGGERED BEFORE THE SYRINGE STOPPED. WHEN THE NURSE ENTERED THE ROOM, THERE WAS NO INDICATOR LIGHT. THE NORADRENALINE SYRINGE WAS PREPARED WITH A CONCENTRATION OF 2 MG IN 50 ML. A CONTINUOUS INFUSION OF NORADRENALINE WAS PLANNED UNTIL THE DECISION OF THE MEDICAL TEAM TO STOP THE ELECTRIC SYRINGE PUMP. HOWEVER, WE FOUND IN OUR SOFTWARE THAT THIS SYRINGE WAS STOPPED AT 3.28PM WITHOUT ANY EXPLANATION. IN VIEW OF THE DOSE OF NORADRENALINE ADMINISTERED TO THE PATIENT, THE INFUSION TIME FOR A 50 ML SYRINGE WAS ESTIMATED AT 1 HOUR 20 MINUTES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058603 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death