BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACE PLUS PERFUSOR®

    MDR report key: 19020488 · Received April 2, 2024

    Report

    Report Number
    9610825-2024-00227
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Report Date
    July 1, 2024
    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). 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 PLUS. ARTICLE NUMBER: 8719030. SERIAL NUMBER/BATCH: (B)(6). SOFTWARE VERSION: 019B0002. HOURS OF OPERATION: 273. SEAL: YES (BLACK PRODUCTION SEAL). FURTHER INFORMATION: N/A. INVESTIGATION RESULTS: HISTORY INSPECTION: THE HISTORY FILES WERE READ AND SENT TO THE RND DEPARTMENT FOR FURTHER INVESTIGATION. ALSO, THE MAIN BOARD OF THE DEVICE WAS SENT IN FOR FURTHER INVESTIGATION. THE RND DEPARTMENT ANSWERED OUR REQUEST TO INVESTIGATE THE HISTORY AND MAINBOARD AS FOLLOWED: THE DEVICE HISTORY AND THE DEVICE MAIN BOARD HAVE BEEN ANALYZED. THE TOO FAST PROCEEDING TIME COULD BE COMPREHENDED FROM THE HISTORY (TIME WAS PROCEEDING MULTIPLE YEARS WITHOUT ANY INTERACTION). DELIVERY WAS NOT AFFECTED SINCE THE DELIVERY FUNCTIONALITY IS BASED ON AN INDEPENDENT TIME BASE. THE ANALYSIS OF THE MAIN BOARD REVEALED A BROKEN CAPACITOR. HOWEVER, THE ERROR PATTERN COULD NOT BE CLEARLY RETRACED TO THE DEFECT. MEASUREMENTS AT THE MAIN BOARD SHOWED THAT THE OSCILLATION FREQUENCY OF THE REAL TIME CLOCK IS IN SPECIFICATION. THE MAIN BOARD SHOULD BE REPLACED DUE TO THE DAMAGE AND TO AVOID RE-OCCURRENCE OF THE FAILURE. IT CANNOT BE EXCLUDED THAT THE CLOCK WAS WRONGLY CONFIGURED ON THE DEVICE BY THE FIRMWARE BUT A SYSTEMATIC ERROR WAS NOT FOUND. THE ROOT CAUSE WILL FURTHER BE ANALYZED. VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS AND THE SEAL ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE WAS IN A CLEAN STATE AND NO DAMAGES WERE DETECTED. FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE DID START USING THE POWER OF THE BATTERY AND PASSED THE SELF-TEST, THE MAINS VOLTAGE WAS CONNECTED, AND THE BATTERY PACK GOT CHARGED. 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 SETTINGS WERE OPENED, AND IT WAS NOTICED THAT THE DATE AND TIME WERE SET TO 2046-01-12, 02:07. AFTER A SHORT MOMENT, THE TIME WAS SHOWING 09:45, AND SO ON. THE DATE AND TIME WERE SET TO THE CURRENT DATE AND TIME, AND THE ERROR PATTERN CONTINUED. DISASSEMBLY: THE ANALYSIS OF THE RND DEPARTMENT OF THE MAIN BOARD REVEALED A BROKEN CAPACITOR. DURING DISASSEMBLY, NO FURTHER DAMAGES COULD BE DETECTED. JUDGMENT: THE COMPLAINT COULD BE CONFIRMED. THE DESCRIBED ERROR PATTERN COULD BE COMPREHENDED DURING THE HISTORY ANALYSIS AND WAS REPRODUCED DURING THE INVESTIGATION. ACCORDING TO THE RND DEPARTMENT, THE ANALYSIS OF THE MAIN BOARD REVEALED A BROKEN CAPACITOR. HOWEVER, THE ERROR PATTERN COULD NOT BE CLEARLY RETRACED TO THE DEFECT. MEASUREMENTS AT THE MAIN BOARD SHOWED THAT THE OSCILLATION FREQUENCY OF THE REAL TIME CLOCK IS IN SPECIFICATION. THE MAIN BOARD SHOULD BE REPLACED DUE TO THE DAMAGE AND TO AVOID RE-OCCURRENCE OF THE FAILURE. IT CANNOT BE EXCLUDED THAT THE CLOCK WAS WRONGLY CONFIGURED ON THE DEVICE BY THE FIRMWARE BUT A SYSTEMATIC ERROR WAS NOT FOUND. THE ROOT CAUSE WILL FURTHER BE ANALYZED.

    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. 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 CUSTOMER: "DEVICE NOT KEEPING THE RIGHT TIME, WHEN TIME WAS SET CORRECTLY AFTER 4 MINUTES IT HAD PASSED 24HOURS ON THE DEVICE. 1. WAS THERE ANY PATIENT, USER HARM AS A RESULT OF THE INCIDENT? IF SO, PLEASE PROVIDE FURTHER CLINICAL INFORMATION SUCH AS PATIENT OUTCOME AND ANY ADDITIONAL THERAPY REQUIRED AS A RESULT. NO HARM AS A RESULT OF THE FAULT. 2. WHICH PROCEDURE WAS BEING CARRIED OUT AT THE TIME? NO PROCEDURE BEING CARRIED OUT AT THE TIME. STAFF NOTICED BEFORE A PROCEDURE THAT THE DEVICE WAS COMING UP WITH A MESSAGE SAYING SERVICE DUE. 3. WAS THERE ANY DELAY TO THE PROCEDURE AS A RESULT OF THIS INCIDENT? IF SO, PLEASE QUANTIFY AS ACCURATELY AS POSSIBLE. NO DELAY TO THE PROCEDURE, STAFF USED A DIFFERENT PUMP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767767 SPACE PLUS PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8719030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown