BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA VP MC WIFI SE

    MDR report key: 21594007 · Received March 13, 2025

    Report

    Report Number
    3004548776-2025-00191
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 24, 2025
    Report Date
    January 21, 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

    Additional Manufacturer Narrative · 0

    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, 3004548776-2025-00135, 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, 3004548776-2025-00192, 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.

    Additional Manufacturer Narrative · 0

    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. 3004548776-2025-00135. 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. 3004548776-2025-00178. 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. 3004548776-2025-00192. 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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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 (B)(4). 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
    1521798 AGILIA VP MC WIFI SE INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S Z019750

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown