BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 17184048 · Received June 22, 2023

    Report

    Report Number
    9610825-2023-00150
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Report Date
    June 22, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN INVESTIGATED IN OUR SERVICE DEPARTMENT AT B. BRAUN MELSUNGEN AG, MELSUNGEN, GERMANY: THE HISTORY FILES WERE READ AND SENT TO THE RND DEPARTMENT FOR FURTHER INVESTIGATION. THE MESSAGE IS DISPLAYED WHEN THE TOM SLAVE NO LONGER RECEIVES A HEARTBEAT SIGNAL FROM THE TOM MASTER. TOM SLAVE: PERFUSOR 88434. TOM MASTER: PERFUSOR 88436. IN ALL 3 CASES, THE TOM SLAVE CORRECTLY DISPLAYS THE MESSAGE "CONNECTION LOST", BECAUSE IN ALL 3 CASES THE INFUSION WAS STOPPED AT THE MASTER. STOPPING THE INFUSION AT THE MASTER LEADS TO A TERMINATION OF TOM AT THE MASTER AND CONSEQUENTLY THE MASTER DOES NOT SEND A TOM HEARTBEAT SIGNAL. THE MISSING TOM HEARTBEAT SIGNAL OF THE MASTER IS DETECTED BY THE TOM SLAVE AND REPORTED TO THE USER WITH THE MESSAGE "CONNECTION ERROR". A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS WERE MISSING. THE TECHNICAL SEAL WAS AVAILABLE AND UNDAMAGED. THE DEVICE SHOWS AGE RELATED SIGNS OF WEAR AND TEAR AND A DAMAGE ON THE LOWER HOUSING WAS FOUND. A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSES THE SELF-TEST. AN OPS 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. THE TAKEOVER MODE WAS CHECKED IN COMBINATION WITH THE SPACE STATION (400594238): THE PUMP WAS INTEGRATED INTO THE SPACE STATION ALONG WITH A SECOND PUMP. A BD 50ML PLASTIPAK SYRINGE WAS INSERTED, AND A DRUG SELECTED. THE MASTER PUMP WAS STARTED. A BD 50ML PLASTIPAK SYRINGE WAS ALSO INSERTED INTO THE SECOND PUMP AND THE SAME DRUG WAS SELECTED. THE TOM MODE WAS RELIABLY DETECTED. THE SLAVE PUMP IS READY. IF THE SYRINGE OF THE MASTER PUMP IS EMPTY, THE SLAVE PUMP RELIABLY STARTS TO DELIVER AND TAKES OVER THE INFUSION OF THE MASTER PUMP. NO MALFUNCTIONS WERE DETECTED. THE FUNCTIONS OF THE MASTER PUMP AND SLAVE PUMP WERE SWAPPED, AND THE PROCESS WAS REPEATED; NO MALFUNCTIONS WERE DETECTED. THE FUNCTION WAS CHECKED AT ALL SLOTS OF THE SPACE STATION. THE DEVICE WAS DISASSEMBLED, AND THE INSIDE WAS INVESTIGATED. THE INSIDE WAS SLIGHTLY DIRTY BUT THERE COULD BE NO ADDITIONAL HARM. ALSO, NO DAMAGES ON THE CLAW MECHANISM WERE FOUND. BECAUSE OF THE "UNABLE TO OPEN CLAW" ERROR DURING THE FUNCTIONAL TEST, THE CLAW MECHANISM WILL BE CHANGED. NO OTHER ABNORMALITIES WERE FOUND. THE COMPLAINT COULD NOT BE CONFIRMED. DURING THE INVESTIGATION, A MALFUNCTION OF THE TAKEOVER MODE COULD NOT BE REPRODUCED. IN ALL 3 CASES, THE TOM SLAVE CORRECTLY DISPLAYS THE MESSAGE "CONNECTION LOST", BECAUSE IN ALL 3 CASES THE INFUSION WAS STOPPED AT THE MASTER. 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

    AS REPORTED BY THE USER FACILITY BY BBM SALES ORGANIZATION IN BELGIUM: "TAKE OVER MODE - CONNECTION ERROR. " ACCORDING TO THE CUSTOMER: "THE TAKE OVER MODE BETWEEN TWO PERFUSOR SPACE HAS BEEN DEFICIENT WITH MESSAGE "CONNECTION ERROR". THE PATIENT IS DEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027864 PERFUSOR SPACE SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown