BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 17499006 · Received August 10, 2023

    Report

    Report Number
    9610825-2023-00379
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Date of Event
    June 27, 2023
    Report Date
    November 3, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    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 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: 1. GENERAL INFORMATION: COMPLAINT: (B)(4). 2. INFORMATION TO THE SAMPLE: 2.1 MODEL: PERFUSOR SPACE. 2.2 ARTICLE NUMBER: 8713030. 2.3 SERIAL NUMBER/BATCH: (B)(4). 2.4 SOFTWARE VERSION: N030004. 2.5 HOURS OF OPERATION: 7039. 2.6 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. THE DEVICE HISTORY ON 2023-06-26 AND 2023-06-27 WAS INVESTIGATED. AN INFUSION WAS STARTED ON 2023-06-26 AT 11:53 WAS STARTED WITH A RATE OF 2ML/H ABOUT 24 HOURS. A FEW SECONDS LATER THE MAINS CONNECTION WAS DISCONNECTED. ON THE NEXT DAY AT 07:12 THE BATTERY WAS NEARLY EMPTY. THE INFUSION STOPPED BECAUSE THE SYRINGE IS EMPTY AND AT 07:42 A BATTERY ALARM OCCURRED. THREE MINUTES LATER THE PUMP SWITCHED OFF BECAUSE THE BATTERY IS EMPTY. BASED ON THE DEVICE HISTORY, NO MAINS CONNECTION WAS CONNECTED. 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. THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGE ARE TO LOCATE. ALSO, A VISUAL INSPECTION ON THE POWER SUPPLY WAS PERFORMED. ONE PIN WAS SLIGHTLY BENT, AND THE LOCK WAS BROKEN. THIS DAMAGE HAS NO EFFECT ON THE FUNCTION. 3.3 FUNCTIONAL INSPECTION: 3.3.1 A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED THE SELF-TEST. A OMNIFIX 50ML SYRINGE WAS INSERTED, THE PUMP IDENTIFIED THE SYRINGE, AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. 3.3.2 THE DELIVERED POWER SUPPLY WAS CONNECTED TO THE DEVICE AND WAS RELIABLY DETECTED. NO MALFUNCTION COULD BE DETECTED. ALSO, THE POWER SUPPLY WAS CONNECTED TO A TEST DEVICE FROM THE SERVICE REPAIR SHOP. IT WAS RELIABLY DETECTED, AND NO MALFUNCTION COULD BE DETECTED. 3.4 INDIVIDUAL INSPECTION: THE BATTERY WAS LOADED, AND A TEST INFUSION WAS STARTED WITHOUT THE MAINS CONNECTION. AN OPS 50ML SYRINGE WAS INSERTED AND A INFUSION WITH 1ML/H WAS STARTED. WHEN THE BATTERY IS NEAR EMPTY, A PRE ALARM OCCURRED AND 30 MINUTES LATER A BATTERY ALARM OCCURRED. 3 MINUTES AFTER THE BATTERY ALARM, THE PUMP SWITCHED OFF BECAUSE THE BATTERY IS EMPTY. THE SYRINGE REMAINS IN POSITION. THE BATTERY WAS TESTED ACCORDING TO THE TECHNICAL SAFETY CHECK. DURING THE TEST, NO MALFUNCTION COULD BE DETECTED. 3.5 DISASSEMBLING: DURING THE INVESTIGATION NO FAULTS COULD BE DETECTED. TO INVESTIGATE THE INSIDE OF THE DEVICE, ONLY THE UPPER HOUSING WAS REMOVED. NO DAMAGE OR SOILING COULD BE FOUND. 4. JUDGMENT: 4.1 THE COMPLAINT COULD NOT BE CONFIRMED. DURING THE INVESTIGATION, NO MALFUNCTION COULD BE DETECTED. 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 (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: "DEATH SUSPICION." ACCORDING TO THE CUSTOMER: "SYRINGE PUMP RENTED TO THE COMPANY BASTIDE MÉDICAL BY THE DPL DEPARTMENT OF CH MARCHANT FOR PROVISION IN THE CARE UNIT OF THE JARDIN DES SILOS (CH MARCHANT). EQUIPMENT DELIVERED TO THE DEPARTMENT BY BASTIDE MEDICAL. ON (B)(6) 2023 IN THE MORNING (8 A.M.), A NURSE FROM THE DEPARTMENT FOUND THE SYRINGE PUMP SWITCHED OFF AND THE PLUNGER RETRACTED (QUANTITY INJECTED INTO THE PATIENT?). THE SYRINGE PUMP IS CORRECTLY CONNECTED TO THE MAINS BUT THE SYRINGE PUMP INDICATES INSUFFICIENT BATTERY. CONTACT WITH BASTIDE MÉDICAL'S ON-CALL DUTY FOR WHAT TO DO: BASTIDE COMES TO COLLECT THE SYRINGE PUMP FOR ANALYSIS AND LOAN OF A NEW DEVICE. MEDICAL LINK FOR ACTION TO BE TAKEN CONCERNING THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759027 PERFUSOR SPACE SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown