BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFUSOR®

    MDR report key: 18320947 · Received December 13, 2023

    Report

    Report Number
    9610825-2023-00577
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    October 22, 2023
    Report Date
    March 13, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER: (B)(4). 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)(6), 2.4 SOFTWARE VERSION: N030004, 2.5 HOURS OF OPERATION: 27461, 2.6 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE DEVICE HISTORY FILES FROM ON (B)(6) 2023 WERE INVESTIGATED. A OPS 50ML SYRINGE WAS SELECTED AND THE INFUSION STARTED WITH A RATE OF 1, 2 ML/H AT 01:02PM. AT 07:14 PM, THE INFUSION STOPPED WITH THE ERROR CODE " SYRINGE NOT CORRECT INSERTED". THE INFUSION WAS CONTINUED AND A FEW SECONDS LATER THE ERROR CODE OCCURRED AGAIN. THE REASON FOR THE ALARM COULD NOT BE CLARIFIED. THE SYRINGE WAS EXTRACTED. NO OTHER ABNORMALITIES WERE FOUND IN THE DEVICE HISTORY. 3.2 VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE TECHNICIAN SEAL (49-03-043) ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE SHOWS AGE RELATED SIGNS OF WEAR AND TEAR AND A DAMAGE ON THE DRIVE HEAD COULD BE DETECTED. THE DAMAGE ON THE DRIVE HEAD IS DUE TO AN IMPACT DAMAGE. 3.3 FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSES THE SELF TEST. A 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. 3.4 INDIVIDUAL INSPECTION: A LONG TERM TEST ABOUT 24 HOURS WAS PERFORMED. A OPS 50ML SYRINGE WAS INSERTED AND THE INFUSION STARTED WITH A RATE OF 1ML/H. DURING THE LONG TERM TEST, NO MALFUNCTION COULD BE DETECTED. SYRINGE SIZE DETECTION WAS CHECKED ACCORDING TO THE CHECK AFTER REPAIR PROTOCOL. THE 9MM DIAMETER GAUGE WAS INSERTED AND WAS WITH A FUP VALUE OF 9,1 INSIDE THE TOLERANCE (FUP VALUE MUST BE BETWEEN 8.6 AND 9.4) THE 32MM DIAMETER GAUGE WAS INSERTED AND WAS WITH A FUP VALUE OF 31,9 INSIDE THE TOLERANCE (FUP VALUE MUST BE BETWEEN 31.6 AND 32.4). 3.5 DISASSEMBLING: THE DEVICE WAS DISASSEMBLED AND THE INSIDE WAS INVESTIGATED. INSIDE THE DEVICE WAS SLIGHTLY DIRTY AND A DAMAGE INSIDE THE DRIVE HEAD COULD BE FOUND. THE REASON FOR THE DAMAGE IS AN IMPACT DAMAGE. 3.6 TEST EQUIPMENT: DESCRIPTION: TYP NR.: LAB.-ID.-NR. N/A, N/A, N/A. 3.7 FOR EXAMINATION USED DISPOSABLES: DESCRIPTION: REF.: LOT: OPS 50ML SYRINGE, (B)(4), 22D28D8001. 4. JUDGMENT: 4.1 THE COMPLAINT COULD NOT BE CONFIRMED. DURING THE INVESTIGATION THE MALFUNCTION COULD NOT BE REPRODUCED. THE MALFUNCTION COULD BE FOUND IN THE DEVICE HISTORY AND IT COULD NOT BE EXCLUDED THAT THE MALFUNCTION OCCURRED BECAUSE OF AN IMPACT DAMAGE. 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 INFORMATION BY BBM SALES ORGANIZATION IN GERMANY: "ERROR MESSAGE SYRINGE INVALID". IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT A PERFUSOR SPACE (MATERIAL # 8713030, SN (B)(6)) WAS BEING USED TO INFUSE NOREPINEPHRINE ON OCTOBER 22, 2023. ACCORDING TO THE COMPLAINANT, AFTER APPROXIMATELY FIVE (5) HOURS OF OPERATION, THE PUMP ALARMED FOR SYRINGE INVALID. THE NURSE INDICATED THAT THE PERFUSOR SPACE PUMP WAS INFUSING NOREPINEPHRINE AT A RATE OF 0.1 MICROGRAMS PER KILOGRAM PER MINUTE (UG/KG/MIN). REPORTEDLY, THE ADMINISTRATION OF THIS MEDICATION WAS NO LONGER POSSIBLE AS A RESULT OF THE ALARM. THE PERFUSOR SYRINGE WAS INSERTED INTO ANOTHER PERFUSOR PUMP TO CONTINUE WITH THIS INFUSION. REPORTEDLY, THE "PATIENT HAD TO BE RESUSCITATED," HOWEVER, THE CIRCUMSTANCES RELATED TO THIS PATIENT EVENT ARE NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655440 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other