AGILIA VP MC WIFI SE
Report
- Report Number
- 3004548776-2025-00135
- Event Type
- Malfunction
- Date Received
- March 11, 2025
- Date of Event
- February 24, 2025
- Report Date
- January 5, 2026
- Manufacturer
- FRESENIUS VIAL S.A.S
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
RELATED REPORTED NUMBER: 3004548776-2025-00126, 3004548776-2025-00127, 3004548776-2025-00128, 3004548776-2025-00129, 3004548776-2025-00130, 3004548776-2025-00131, 3004548776-2025-00132, 3004548776-2025-00133, 3004548776-2025-00134, 3004548776-2025-00136, 3004548776-2025-00137, 3004548776-2025-00138, 3004548776-2025-00139, 3004548776-2025-00140, 3004548776-2025-00141, 3004548776-2025-00142, 3004548776-2025-00143, 3004548776-2025-00144, 3004548776-2025-00145, 3004548776-2025-00146, 3004548776-2025-00147, 3004548776-2025-00148, 3004548776-2025-00149, 3004548776-2025-00150, 3004548776-2025-00151, 3004548776-2025-00152, 3004548776-2025-00153, 3004548776-2025-00154, 3004548776-2025-00155, 3004548776-2025-00156, 3004548776-2025-00157, 3004548776-2025-00158, 3004548776-2025-00159, 3004548776-2025-00160, 3004548776-2025-00161, 3004548776-2025-00162, 3004548776-2025-00163, 3004548776-2025-00164, 3004548776-2025-00165, 3004548776-2025-00166, 3004548776-2025-00167, 3004548776-2025-00168, 3004548776-2025-00169, 3004548776-2025-00170, 3004548776-2025-00171, 3004548776-2025-00172, 3004548776-2025-00173, 3004548776-2025-00174, 3004548776-2025-00175, 3004548776-2025-00176, 3004548776-2025-00177, 3004548776-2025-00178, 3004548776-2025-00179, 3004548776-2025-00180, 3004548776-2025-00181, 3004548776-2025-00182, 3004548776-2025-00183, 3004548776-2025-00184, 3004548776-2025-00185, 3004548776-2025-00186, 3004548776-2025-00187, 3004548776-2025-00188, 3004548776-2025-00189, 3004548776-2025-00190, 3004548776-2025-00191, 3004548776-2025-00192, 3004548776-2025-00193, 3004548776-2025-00194, 3004548776-2025-00195, 3004548776-2025-00196, 3004548776-2025-00197, 3004548776-2025-00198, 3004548776-2025-00199, 3004548776-2025-00200, 3004548776-2025-00201, 3004548776-2025-00202, 3004548776-2025-00203.
3000240707-2025-00126, 3004548776-2025-00127, 3004548776-2025-00128, 3004548776-2025-00129, 3004548776-2025-00130, 3004548776-2025-00131, 3004548776-2025-00132, 3004548776-2025-00133, 3004548776-2025-00134, 3004548776-2025-00136, 3004548776-2025-00137, 3004548776-2025-00138, 3004548776-2025-00139, 3004548776-2025-00140, 3004548776-2025-00141, 3004548776-2025-00142, 3004548776-2025-00143, 3004548776-2025-00144, 3004548776-2025-00145, 3004548776-2025-00146, 3004548776-2025-00147, 3004548776-2025-00148, 3004548776-2025-00149, 3004548776-2025-00150, 3004548776-2025-00151, 3004548776-2025-00152, 3004548776-2025-00153, 3004548776-2025-00154, 3004548776-2025-00155, 3004548776-2025-00156, 3004548776-2025-00157, 3004548776-2025-00158, 3004548776-2025-00159, 3004548776-2025-00160, 3004548776-2025-00161, 3004548776-2025-00162, 3004548776-2025-00163, 3004548776-2025-00164, 3004548776-2025-00165, 3004548776-2025-00166, 3004548776-2025-00167, 3004548776-2025-00168, 3004548776-2025-00169, 3004548776-2025-00170, 3004548776-2025-00171, 3004548776-2025-00172, 3004548776-2025-00173, 3004548776-2025-00174, 3004548776-2025-00175, 3004548776-2025-00176, 3004548776-2025-00177, 3004548776-2025-00178, 3004548776-2025-00179, 3004548776-2025-00180, 3004548776-2025-00181, 3004548776-2025-00182, 3004548776-2025-00183, 3004548776-2025-00184, 3004548776-2025-00185, 3004548776-2025-00186, 3004548776-2025-00187, 3004548776-2025-00188, 3004548776-2025-00189, 3004548776-2025-00190, 3004548776-2025-00191, 3004548776-2025-00192, 3004548776-2025-00193, 3004548776-2025-00194, 3004548776-2025-00195, 3004548776-2025-00196, 3004548776-2025-00197, 3004548776-2025-00198, 3004548776-2025-00199, 3004548776-2025-00200, 3004548776-2025-00201, 3004548776-2025-00202, 3004548776-2025-00203.
THE FOLLOWING HAS BEEN REPORTED: AN INCREASE OF AIR ALARMS HAS BEEN NOTICED BY SEVERAL INDEPENDENT DEPARTMENTS AFTER UPGRADING THE VP PUMP FROM SW 4.1 TO 4.2B. THE ALARM RATE IS A LOT HIGHER THAN BEFORE AND NO AIR IN THE LINES ARE FOUND AFTER RECEIVING THE ALARM ACCORDING TO THE CLIENTS. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EVENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.
SOME DEVICE HISTORY RECORDS WERE REVIEWED AND NOTHING WAS FOUND RELATED TO THE REPORTED EVENT. DEVICE LOG HISTORY REGARDING THE RECEIVED PUMP WAS REVIEWED. SEVERAL AIR ALARMS WERE IDENTIFIED BUT ALTHOUGH THIS COULD CONFIRM THE REPORTED EVENT (AIR IN LINE), THOSE INFORMATION ARE INSUFFICIENT TO CONFIRM A QUALITY ISSUE AS ALARMS ARE DESIGNED TO INFORM THE USER THAT THE INFUSION NEEDS TO BE ATTENDED. ONE REPORTED DEVICE AND 5 DEFECTIVE AIR SENSORS WERE RECEIVED IN BRÉZINS FOR INVESTIGATION. A LENGTHY INVESTIGATION INTO EVENT WAS CARRIED OUT BY THE R&D TEAM. IT HAS BEEN SHOWN THAT THE AIR DETECTION LEVELS OF THE LAST SOFT (SW. 4.2 AND 4.3) HAVE BEEN LOWERED IN ORDER TO BETTER DETECT SMALL BUBBLES (<10L) WHICH WORKS VERY WELL WITH NEW VERSIONS OF AIR SENSORS. THE ISSUE IS THAT WITH SLIGHTLY OLDER AIR SENSORS, THE DETECTION THRESHOLD IS TOO CLOSE TO THE LIMIT, TOO SENSITIVE. THEREFORE, SEVERAL ACTIONS ARE BEING CARRIED OUT. AN FSN HAS BEEN SENT, DEALT BY THE EVENT, FRESENIUS KABI RECOMMENDS TO ALL CUSTOMERS: ·WHEN RELOCATING PUMP STATIONS, ALWAYS MOVE THE ROLLING STAND ITSELF, RATHER THAN PULLING ON THE TUBE SETS. ·WHEN INSTALLING TUBE SETS, TO USE THE HOOK ON THE LEFT SIDE OF THE PUMP HOUSING TO SECURE THE TUBE SET AND KEEP IT IN PLACE THROUGHOUT THE INFUSION. A SOFTWARE CORRECTION TO PREVENT FROM THESE FALSE AIR ALARMS IS IN PREPARATION, DEALT BY THE EVENT AND CCR. A HARDWARE INVESTIGATION IS ALSO UNDERWAY ON THE AIR SENSORS IN THE FIELD VIA CAPA. WE REMIND YOU THAT BEFORE UPGRADING, IT IS IMPORTANT TO FOLLOW THE TSB0455. THIS COMPLAINT IS CONSIDERED AS VALID, AND THE ROOT CAUSE IS RELATED TO A SOFTWARE ISSUE. TO OUR KNOWLEDGE THIS COMPLAINT IS NOT BEING RELATED TO PATIENT SAFETY THIS COMPLAINT IS CONSIDERED AS: VALID. THE TREND IS: ABNORMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 338346 | AGILIA VP MC WIFI SE | INFUSION PUMP SYSTEM | FRN | FRESENIUS VIAL S.A.S | Z019750 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |