BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA SP MC CO

    MDR report key: 25035443 · Received April 29, 2026

    Report

    Report Number
    3000240707-2026-00176
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 8, 2026
    Report Date
    April 29, 2026
    Manufacturer
    FRESENIUS VIAL S.A.S
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED CASES: 3000240707-2026-00136. 3000240707-2026-00137. 3000240707-2026-00138. 3000240707-2026-00139. 3000240707-2026-00140. 3000240707-2026-00141. 3000240707-2026-00142. 3000240707-2026-00143. 3000240707-2026-00144. 3000240707-2026-00145. 3000240707-2026-00146. 3000240707-2026-00147. 3000240707-2026-00148. 3000240707-2026-00149. 3000240707-2026-00150. 3000240707-2026-00151. 3000240707-2026-00172. 3000240707-2026-00173. 3000240707-2026-00174. 3000240707-2026-00175. 3000240707-2026-00177. 3000240707-2026-00178.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: THE MEDTECH COLOMBIA TECHNICAL SERVICE DEPARTMENT REPORTS THAT, FOLLOWING AN INSPECTION OF SEVERAL INFUSION PUMPS AT BODEGA CELTA FK, (B)(6) HOSPITAL, (B)(6) HOSPITAL, AND (B)(6) HOSPITAL, (B)(4) UNITS WERE IDENTIFIED WITH THE "ERROR 51" SPEAKER ALARM. I AM SHARING THE CONSOLIDATED FILE OF THE FULL INSPECTION. THE MEDTECH COLOMBIA TECHNICAL SERVICE ENGINEER FOLLOWED THE STEPS OUTLINED. IDENTIFYING THAT THE ERROR WAS DUE TO THE LOW VOLUME OF THE ALARM, WHICH CAUSED AN ERROR IN THE EQUIPMENT AS IT WAS UNABLE TO VERIFY THAT THE AUDIBLE ALARM HAD BEEN GENERATED. FOLLOWING TSB'S INSTRUCTIONS, A TICKET WAS OPENED IN KEY2 FOR THESE (B)(4) UNITS UNDER REFERENCE NUMBER. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EVENT EFFECTS WERE REPORTED. DEVICE HISTORY RECORD WAS NOT REVIEWED AS THIS IS A KNOWN ISSUE FOR WHICH THE ROOT CAUSE HAS BEEN INVESTIGATED AS PART OF A CAPA. CORRECTIVE ACTIONS ARE CURRENTLY BEING IMPLEMENTED IN THE MANUFACTURING PROCESS DEVICE LOG WAS NOT PROVIDED AND EXTRACTED: ISSUE KNOWN; THEREFORE, NO REVIEW COULD BE PERFORMED. THE DEVICE WAS NOT RECEIVED IN BRÉZINS FOR INVESTIGATION. ERROR 51 ON THE AGILIA CONNECT RANGE IS A KNOWN ISSUE FOR WHICH CAPA WAS OPENED IN MAY 2023. THE INVESTIGATION INTO THIS ERROR HAS SHOWN THAT ITS ROOT CAUSES ARE MAINLY RELATED TO TWO COMPONENTS: FLEXIBLE IC FLEX BINDER ASSEMBLY (WHICH INCLUDES THE SPEAKER AND BINDER SOCKET) POWER SUPPLY BOARD (FOR AGILIA SP & VP). IT IS RECOMMENDED TO REPLACE THESE PARTS IF THIS ERROR OCCURS. FURTHER INVESTIGATIONS ARE ONGOING, AND CORRECTIVE ACTIONS ARE BEING IMPLEMENTED AND TRACKED WITHIN THE CAPA TO RESOLVE THIS TYPE OF ISSUE. BASED ON THE INFORMATION PROVIDED, AS WELL AS OUR PRIOR KNOWLEDGE OF THIS TYPE OF MALFUNCTION, THE CLAIM IS CONSIDERED SUBSTANTIATED. THIS COMPLAINT HAS BEEN ADDED TO OUR TREND FOR STATISTICAL MONITORING. TO OUR KNOWLEDGE THIS COMPLAINT IS NOT BEING RELATED TO PATIENT SAFETY. THIS COMPLAINT IS CONSIDERED AS: VALID. THE TREND IS: ABNORMAL. KABITRACK RECORD(S): CAPA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284529 AGILIA SP MC CO INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S Z018641

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown