BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFUSOR SPACE

    MDR report key: 16019251 · Received December 20, 2022

    Report

    Report Number
    9610825-2022-00542
    Event Type
    Injury
    Date Received
    December 20, 2022
    Date of Event
    November 23, 2022
    Report Date
    November 13, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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)(6). 2.4 SOFTWARE VERSION: N030005. 2.5 HOURS OF OPERATION: 103 HOURS. 2.6 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. THE HISTORY FILES FROM 2022-11-23 (SPECIFIED DATE OF THE INCIDENT, GIVEN FROM THE CUSTOMER) WERE INVESTIGATED. AT 2022-11-23 11:00 AM A TERUMO 30 ML SYRINGE WAS SELECTED. THE RATE WAS SET TO 90 ML/H AND THE VTBI TO 12 ML. THE INFUSION WAS STARTED AT 11:05 AM. THE INFUSION WAS STOPPED AT 11:13 AM BY "VTBI INFUSED" ALARM. UP TO THAT TIME THE DEVICE HAS DELIVERED 12 ML. FURTHERMORE, NO ANOMALIES COULD BE DETECTED INSIDE THE HISTORY FILES. 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. THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGED PARTS ARE TO LOCATE. 3.3 FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED THE SELF-TEST. A B.BRAUN OPS 50 ML 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. 3.4 INDIVIDUAL INSPECTION FLOWRATE: B.BRAUN OPS 50 ML 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 +0,55%. ACCURACY OF SET DELIVERY RATE SHOULD BE ± 2 % ACCORDING TO IEC/EN 60601-2-24. INDIVIDUAL INSPECTION FLOWRATE: B.BRAUN OPS 20 ML 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 +0,85%. ACCURACY OF SET DELIVERY RATE SHOULD BE ± 2 % ACCORDING TO IEC/EN 60601-2-24. 3.5 INDIVIDUAL INSPECTION: THE CUSTOMER DESCRIBED THAT A BD PLASTIPAK SYRINGE WAS INSERTED. FURTHERMORE, PICTURES WITH AN INSERTED BD PLASTIPAK 20 ML SYRINGE WERE PROVIDED. FOR CHECKING THE COMPLAINT MALFUNCTION A BD PLASTIPAK 20 ML SYRINGE WAS INSERTED INCORRECTLY. THEN YOU COULD SELECT A TERUMO 30 ML SYRINGE. THE COMPLAINT INFUSION WAS REPRODUCED. THE BD PLASTIPAK 20 ML SYRINGE WAS MOUNTED UP TO 13 ML BUT WAS INSERTED INCORRECTLY. THEN A TERUMO 30 ML SYRINGE WAS SELECTED. THE RATE WAS SET TO 90 ML/H AND THE VTBI TO 12 ML. THE INFUSION WAS STARTED. 8 MINUTES LATER, THE INFUSION WAS STOPPED CORRECTLY. THERE WAS A RESIDUAL VOLUME OF APPROX. 5 ML IN THE SYRINGE. 3.6 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. SUMMING UP ALL TESTS, THE PERFUSOR SPACE OPERATED WITHIN OUR SPECIFICATION. NO FLOW RATE DEVIATION. THE COMPLAINT MALFUNCTION IS DUE TO WRONG USER HANDLING. THE CUSTOMER INSERTED A BD PLASTIPAK 20 ML SYRINGE BUT WAS SELECTED A TERUMO 30 ML SYRINGE. FOR A TERUMO 30 ML SYRINGE TO BE SELECTED AT ALL WHEN A BD PLASTIPAK 20 ML SYRINGE IS INSERTED, IT MUST HAVE BEEN INSERTED INCORRECTLY BY THE CUSTOMER. THAT COULD BE REPRODUCED. ADDITION INFORMATION: FROM IFU: PAGE 15 CONFIRM SYRINGE TYPE WITH TYPE OF SYRINGE INDICATED MUST COINCIDE WITH SYRINGE INSERTED. 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 AUSTRALIA: "UNDERINFUSION." CUSTOMER INFORMATION: "PARTICIPANT TO BE DOSED ON (B)(6) 2022 STARTED THEIR IP INFUSION AT 11:00. THE DOSING TEAM HAD PREPARED THE IP IN ACCORDANCE WITH APPROVED DOSING INSTRUCTIONS AT 10:40 AND TOOK PHOTOGRAPHIC EVIDENCE AS REQUIRED FOR ACCOUNTABILITY. INFUSION RATE WAS SET AT 15MG/MIN OR 1.5ML/MIN OR 90ML/HOUR. AT THE END OF DOSING THERE WAS ONLY SUPPOSED TO BE 0.1MLS OF IP LEFT IN THE SYRINGE HOWEVER, FOR THIS PARTICIPANT 4MLS WAS LEFT IN THE SYRINGE THEREBY IMPLYING THAT THE PARTICIPANT WAS UNDERDOSED. DOSING TEAM EXITED THE ROOM AND INFORMED STUDY TEAM. THE PUMP, LINES, AND SYRINGE WERE PHOTOGRAPHED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142499 PERFUSOR SPACE SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown