PERFUSOR SPACE
Report
- Report Number
- 9610825-2023-00097
- Event Type
- Malfunction
- Date Received
- April 5, 2023
- Report Date
- July 18, 2023
- Manufacturer
- B.BRAUN MELSUNGEN AG
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (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.
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT 400589466. 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: INFUSOMAT SPACE 2.2 ARTICLE NUMBER: 8713050 2.3 SERIAL NUMBER/BATCH: 463667 2.4 SOFTWARE VERSION: N030004 2.5 HOURS OF OPERATION: 15377 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 2023-01-15 TO 2023-01-16 (SPECIFIED DATE OF THE INCIDENT, GIVEN FROM THE CUSTOMER) WERE INVESTIGATED. AT 2023-01-15 19:37 PM A RATE OF 250 ML/H AND A VTBI OF 250 ML WAS SET. IN THE SAME MINUTE THE DRUG AMIOD LD WAS SELECTED. AT 19:53 PM A SPACE LINE WAS INSERTED, AND THE INFUSION WAS STARTED. IN THE SAME MINUTE AN AIR BUBBLE ALARM WAS DISPLAYED (REASON FOR THAT COULD NOT BE CLARIFIED). THE LINE WAS PURGED, AND THE INFUSION WAS STARTED AGAIN AT 19:54 PM. THE INFUSION WAS STOPPED AT 20:50 PM BY THE CUSTOMER (VTBI PRE-ALARM WAS DISPLAYED AT THAT TIME). UP TO THAT TIME THE PUMP HAS DELIVERED A VOLUME OF 236,57 ML. AT 2023-01-15 21:00 PM THE RATE WAS SET TO 22 ML/H AND THE VTBI TO 500 ML. THE DRUG AMIOD.9 WAS SELECTED. THE INFUSION WAS STARTED AT 21:01 PM. THE INFUSION WAS STOPPED BY AN AIR RATE ALARM AT 2023-01-16 10:26 AM. THE INFUSION WAS STARTED AGAIN ONE MINUTE LATER. THE INFUSION WAS STOPPED AGAIN FOUR MINUTES LATER AT 10:31 AM BY AN AIR BUBBLE ALARM. THE INFUSION WAS STARTED AGAIN AT 11:14 AM. AT 11:24 AM THE INFUSION WAS STOPPED AGAIN BY AN AIR RATE ALARM. UP TO THAT TIME THE DEVICE HAS DELIVERED A VOLUME OF 300,45 ML. DURING THE SECOND INFUSION WITH THE DRUG AMIOD.9 THE LINE WAS NEVER PURGED. THEREFORE, SEVERAL AIR ALARMS INTERRUPTED THE INFUSION. 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 WERE INTACT AND UNDAMAGED. THE SEAL ON THE LOWER HOUSING PART WERE NOT AVAILABLE. IN ADDITION, THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGE ARE TO LOCATE. 3.3 FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSES THE SELF-TEST. A SPACE LINE WAS INSERTED, AND THE PUMP IDENTIFIED THE LINE, AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. 3.4 PRESSURE INSPECTION: IN CHECKING THE DOWNSTREAM SENSOR, THE ELECTRONIC PRESSURE CUT-OFF AND THE MECHANICAL PRESSURE LIMITATION OF THE DEVICE WERE TESTED, ACCORDING TO THE REQUIREMENTS OF THE TECHNICAL SAFETY CHECK. THE ELECTRONIC PRESSURE CUT-OFF WAS CHECKED: THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. 3.5 FLOW RATE INSPECTION: A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. HERE A NOMINAL FLOW RATE OF 100 ML/H WAS CHOSEN. THE ASSESSED AVERAGE DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF -0,98%. THE ACCURACY OF SET DELIVERY RATE SHOULD BE: ± 5 % ACCORDING TO IEC/EN 60601-2-24. THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. 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 INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. NO FLOWRATE DEVIATION COULD BE REPRODUCED ORE DETECTED INSIDE THE HISTORY FILES. NO PRODUCT DEVIATION. 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.
AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN UNITED KINGDOM: "UNDERINFUSION". CUSTOMER STATEMENT: "I'VE DOWNLOADED THE LOGS DOE THE PUMP YOU BROUGHT ROUND YESTERDAY FROM WARD 8. LOOKING AT THEM IT LOOKS LIKE THE PUMP WAS SWITCHED ON AT 19:36 ON (B)(6) 2022. AT 19:37 AMIOD LD WAS SELECTED FROM THE DRUG LIBRARY. AN INFUSION WAS THEN STARTED AT 250ML/H AT 19:53 WHICH GAVE AN AIR BUBBLE ALARM STRAIGHT AWAY. THIS WAS PURGED AND THE INFUSION CONTINUED UNTIL 20:50 IT FINISHED IN WHICH 236.57ML HAD BEEN INFUSED. THEN AT 21:00 AMIOD.9 WAS SELECTED WITH AN INFUSION OF 22ML SELECTED. THIS RAN UNINTERRUPTED UNTIL 10.26AM ON (B)(6) 2022 WHERE AN AIR RATE ALARM CAME ON WHICH WAS PROBABLY WHEN THE BAG RAN OUT. AT THIS POINT THE LOG SAYS 295.21ML HAD BEEN INFUSED. LOOKING AT THE LOGS I DON'T THINK THE BAG WAS CHANGED BETWEEN THE AMIOD LD INFUSION AT 19:37 AND THE AMIOD.0 INFUSION AT 21:00 AND THAT'S WHY IT THINKS IT STILL HAS OVER 200ML TO INFUSE. I HAVE ATTACHED THE LOG AND HIGHLIGHTED IN GREEN THE POINTS I HAVE MADE ABOVE. LET ME KNOW WHAT YOU THINK. IF YOU STILL THINK THERE IS AN ISSUE, I CAN HAVE IT SENT TO BBRAUN FOR FURTHER INVESTIGATION, BUT IF NOT I'LL GET ONE OF OUR ENGINEERS TO RUN THROUGH ITS CHECKS AND PUT IT BACK INTO CIRCULATION. I'VE SPOKEN TO THE TEAM ON W8 (SHANNON AND MATTHEW) AND THEY SAY THAT THE LOADING DOSE WAS MADE UP IN A 250ML BAG AND THEN A 500ML BAG WAS PREPARED FOR THE MAINTENANCE DOSE (THEY MAY HAVE USED THE SAME ADMINISTRATION SET). WOULD SEEM APPROPRIATE TO INVESTIGATE THE PUMP WITH BBRAUN JUST IN CASE THERE IS AN ISSUE (ALTHOUGH I SUSPECT THIS WILL NOT BE THE CASE)."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2242590 | PERFUSOR SPACE | PUMP, INFUSION, | FRN | B.BRAUN MELSUNGEN AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |