AGILIA SP MC WIFI GB
Report
- Report Number
- 3004548776-2025-00206
- Event Type
- Malfunction
- Date Received
- March 18, 2025
- Date of Event
- March 6, 2025
- Report Date
- October 27, 2025
- Manufacturer
- FRESENIUS VIAL S.A.S.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
RELATED REPORT NUMBERS 3004548776-2025-00205, 3004548776-2025-00207.
THE FOLLOWING HAS BEEN REPORTED: THE ENCLOSED SYRINGE DRIVER WAS SENT TO OUR MEDICAL PHYSICS LAB FROM OUR NEURO CRITICAL CARE UNIT A COMPLAINT THAT THE SYRINGE WAS UNDER INFUSING. NO PATIENT HARM REPORTED. PUMP HAS ANOMALIES IN THE EVENTS LOGS. THE PUMP DISPLAYING THE "SOFTWARE DEVELOPMENT/DO NOT CONNECT TO PATIENT" MESSAGE WHEN WE TURNED THEM ON IN THE LAB FOR CHECKS. PUMP SN (B)(6): REQUEST DETAILS - PUMP HAS BEEN INVOLVED IN AN INCIDENT, A REPORT UNDER INFUSION. NO PATIENT HARM OCCURRED. UPON RECEIPT IN THE MEDICAL PHYSICS LAB, THE DEVICE WAS CONNECTED TO AGILIA PARTNER SOFTWARE, TIME/DATE VERIFIED, AND EVENT LOG PRINTED/REVIEWED. IT SHOULD BE NOTED THAT IT TOOK SEVERAL ATTEMPTS TO DOWNLOAD THE EVENTS LOG. ACCORDING TO THE DATIX RECEIVED, THE ISSUE SUPPOSEDLY HAPPENED ON 12 JAN 2025 AROUND 10AM. THERE IS NO CORRESPONDING INFUSION IN THE EVENT LOG; ACCORDING TO THE LOGS, SETUP FOR AN INFUSION STARTED AT 17:24:59 ON (B)(6) 2025. THE CORRECT DATASET (GGC ICU SP DRUGLIB2) AND PROFILE (CRITICALCARE) WERE THEN CONFIRMED. AFTER THIS, AT 17:25:14, IT'S NOTED THAT THE SYRINGE SELECTION INFO DOES NOT DISPLAY THE USUAL SYRINGE NAME AND VOLUME, STATING "FIX" INSTEAD OF THE EXPECTED BRAUN OMNIFIX. IT ALSO DISPLAYS AN UNEXPECTED REMAINING VOLUME IN SYRINGE FIGURE OF "1114792.309". FURTHER ALONG, AT 17:25:20, THERE IS AN INFUSION DRUG SELECTION OF HEPARIN; AT THE SAME TIME, THE DRUG SELECTION INFO DISPLAYS THE DRUG NAME AS "EPARIN". AFTER PRIMING THE INFUSION STARTS AT 17:27:08, WITH A RATE OF 1.2ML/HR. THERE IS A RATE CHANGE AT 18:39:02 TO 1.6ML/HR. THERE ARE INSTANCES OF THE PUMP ALARMING OCCLUSION APPROX 20-30 MINUTES FROM THE START UNTIL 20:07:24. A BOLUS (100ML/HR) IS THEN PERFORMED AT 20:10:45. THE INFUSION IS STOPPED ON (B)(6) 2025 AT 00:57:31, WITH A TOTAL OF 13.25ML INFUSED, ACCORDING TO THE LOGS. ANOTHER INFUSION WAS INITIATED AT 6:39:15 ON 13 JAN 2025 WITH THE SIMILAR SETTINGS AND ISSUES AS DETAILED ABOVE IN THE LOGS, STARTING AT 6:40:06 AND ENDING AT 9:15:43 WITH 3.11ML INFUSED. IT IS UNCLEAR IF THIS WAS A SECOND ATTEMPT TO USE THIS ON A PATIENT, OR A "TEST" INFUSION BY USERS. ACCORDING TO THE INCIDENT REPORT FILLED IN BY NEURO CRITICAL CARE STAFF, THE USERS SET UP THE PUMP TO RUN AN INFUSION AT 1.2ML/HR. WHEN THE DEVICE WAS CHECKED, "AFTER A COUPLE OF HOURS" STAFF FELT THAT THE VOLUME IN THE SYRINGE HAD NOT DECREASED ACCORDINGLY. THE CHECKED THE BUILT-IN VOLUME INDICTOR ON THE PUMP, AND IT STATED 0.6ML INFUSED, WHEN IT SHOULD HAVE BEEN 3.6ML. THEY ALSO STATED THAT "THE PUMP HAD NOT ALARMED DURING THIS TIME" TO INDICATE ANY OCCLUSIONS, BUT THEN STATE, "IT HAD ALARMED POSSIBLY 3 TIMES WITH DOWNSTREAM OCCLUSION" DUE TO PATIENT MOVEMENT. ACCORDING TO THE PUMP LOGS, IT WAS SIX. STAFF CHANGED THE RATE TO 1.6ML/HR, BUT SYRINGE HAD NOT MOVED FROM THE 18ML MARK. STAFF DECIDED TO SWITCH TO A DIFFERENT PUMP (582989) WITH A NEW SYRINGE/LINE SETUP. WHEN BROUGHT TO THE LAB ON (B)(6) 2025, AFTER LOGS WERE DOWNLOADED, THE PUMP WAS TURNED ON IN NORMAL OPERATION MODE. IT WAS NOTED THAT THE DEVICE BOOTED UP WITH SOFTWARE DEVELOPMENT MESSAGE, THAT ADVISES THAT THE PUMP IS NOT TO BE CONNECTED TO A PATIENT AT THAT TIME. THERE'S NO INDICATION KNOWINGLY AVAILABLE TO KNOW WHEN THIS MESSAGE BEGAN APPEARING (FROM PREVIOUS EXPERIENCE DEALING WITH THE S/W DEVELOPMENT MESSAGE IN THE LAB, THE MESSAGE CAN LAST A FEW HOURS TO A FEW DAYS - IT'S DEPENDANT ON THE WIFI AND WHETHER THE DEVICE IS PLUGGED INTO THE MAIN POWER). ONCE THE MESSAGE HAS DISAPPEARED, THE DEVICE WAS TURNED ON AND PROGRAMMED TO RUN A INFUSION SIMILAR TO ONE REPORTED: HEPATIN 20000/20ML, 50ML BRAUN OMNIFIX SYRINGE, 1.2ML/HR FOR 2 HOURS. THE DEVICE INDICATED AND DELIVERED THE EXPECTED 2.4ML. ATTEMPTS AT CAUSING AN OCCLUSION AT SIMILAR TO THE ONES INDICATED IN THE EVENT LOG FAILED; COULD NOT REPLICATE AN OCCLUSION AT THAT RATE. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.
THE DEVICE HISTORIES RECORDS WERE REVIEWED, NO EVENT LINKED WITH THE REPORTED ISSUE WAS FOUND. DEVICES LOGS WERE REVIEWED, AND THERE WERE A LOT OF OCCLUSION ALARMS WHICH STOP THE INFUSIONS ON EACH DEVICE AND THE TOTAL VOLUME INFUSED IS REDUCED AFTER AN OCCLUSION. THE REPORTED DEVICES WERE RECEIVED IN BRÉZINS FOR INVESTIGATION. ACCORDING TO OUR INVESTIGATION, IT WAS FOUND THAT THE COVER WAS NOT PUT IN PLACE ON SN(B)(6) DURING THE EXTERNAL CHECK OF BOTH DEVICES. REPRODUCIBLE TESTS WERE THEN CARRIED OUT ON THE THREE DEVICES: FOR SN(B)(6): A FLOWRATE WAS LAUNCHED @ 1.2 ML/H FOR 7 HOURS 30 MINUTES WITH WATER AND UNDER THE SAME CONDITIONS AS HISTORY LOG; DRUG: HEPARINE; DILUTION: 20000UNIT/20ML; PRESSURE THRESHOLD: 400 MMHG. THE FLOW RATE ACCURACY WAS FOUND COMPLIANT COMPARED TO IFU SPECIFICATIONS (+/- 3%). NO ALARM NO DYSFUNCTION DURING THE FLOWRATE TEST. FOR SN(B)(6): A FLOWRATE WAS LAUNCHED @ 1.2 ML/H FOR 6 HOURS 20 MINUTES WITH WATER AND UNDER THE SAME CONDITIONS AS HISTORY LOG; DRUG: HEPARINE; DILUTION: 20000UNIT/20ML PRESSURE THRESHOLD: 400 MMHG. THE FLOW RATE ACCURACY WAS FOUND COMPLIANT COMPARED TO IFU SPECIFICATIONS (+/- 3%). NO ALARM NO DYSFUNCTION DURING THE FLOWRATE TEST. FOR SN(B)(6): A FLOWRATE WAS LAUNCHED @ 1 ML/H FOR 8 HOURS WITH WATER AND UNDER THE SAME CONDITIONS AS HISTORY LOG; DRUG: HEPARINE; DILUTION: 20000UNIT/20ML PRESSURE THRESHOLD: 400 MMHG. THE FLOW RATE ACCURACY WAS FOUND COMPLIANT COMPARED TO IFU SPECIFICATIONS (+/- 3%). NO ALARM NO DYSFUNCTION DURING THE FLOWRATE TEST. OCCLUSION TESTS WERE THEN CARRIED OUT ON THE THREE DEVICES, AND ALL WERE FOUND TO BE COMPLIANT. HOWEVER, ONLY THE OCCLUSION ALARM WAS TRIGGERED NOT THE PRE-ALARM BECAUSE THE PRE-ALARM WAS DISABLED. QUALITY CONTROL CHECKS WERE SUCCESSFULLY COMPLETED WITH NO MALFUNCTIONS DETECTED EXCEPT FOR THE DEVICE SN(B)(6) BECAUSE THE COVER IS NOT CORRECTLY PUT IN PLACE. FOR THIS COMPLAINT, THE REPORTED ISSUE COULD NOT BE REPRODUCED DURING THESE TESTS. BASED ON THE ANALYSIS AND TEST OUTCOMES, NO TECHNICAL CAUSES WHICH COULD HAVE TRIGGERED AN UNEXPECTED OCCLUSION WERE FOUND. THE OCCLUSION ALARMS SEEN IN THE LOGS WERE MOST LIKELY CAUSED BY EXTERNAL FACTORS SUCH AS A CLAMPED TUBE OR CLOSED VALVE IN THE INFUSION LINE, RESULTING FROM INCORRECT USE OF THE DEVICE. THE DEVICE OPERATED IN ACCORDANCE WITH ITS SPECIFICATIONS. REPAIR RECOMMENDED ACTION: UPDATING SOFTWARE VERSION FOR SN(B)(6): PUT THE COVER IN PLACE. TO OUR KNOWLEDGE THIS COMPLAINT IS NOT BEING RELATED TO PATIENT SAFETY. THIS COMPLAINT IS CONSIDERED AS: NOT VALID THE TREND IS: N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 917485 | AGILIA SP MC WIFI GB | INFUSION PUMP SYSTEM | FRN | FRESENIUS VIAL S.A.S. | Z018730 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |