AGILIA VP MC WIFI US Z019735Recalls & reported problems
Fresenius Kabi AG · The Agilia VP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medications, blood and blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, subcutaneous and intraosseous using dedicated administration sets. The Agilia VP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, blood and blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, and subcutaneous using dedicated administration sets. It is intended for use by trained healthcare professionals in healthcare facilities. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04086000856089), received between Aug 12, 2025 and Aug 20, 2026 — classified as 6 malfunctions.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2026No Apparent Adverse Event
The following has been reported:Customer reported up stream occlusion alarm.Reporting as a conservative measure. No Adverse Event effects were reported.Additional information is needed to complete the investigation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50349593 ↗MalfunctionAug 20, 2026No Apparent Adverse Event
The following has been reported:customer reported up stream occlusion alarm.Reporting as a conservative measure. No Adverse Event effects were reported.Additional information is needed to complete the investigation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50349591 ↗MalfunctionDec 2, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: SERVICE ORDER WAS ORIGINALLY CREATED FOR PREVENTATIVE MAINTENANCE BUT DURING PM, AN ISSUE WAS FOUND. 3 YEAR PREVENTATIVE MAINTENANCE - CUSTOMER SENT IN THE ATTACHED REQUEST FORM REPORTING A MAINTENANCE MESSAGE ON SCREEN OF ALL PUMPS. DATES RANGE FROM JULY TO SEPTEMBER. REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE NOT REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23694440 ↗MalfunctionDec 2, 2025No Apparent Adverse Event; No Apparent Adverse Event
DEVICE HISTORY RECORD WAS REVIEWED AND NOTHING WAS FOUND RELATED TO THE REPORTED EVENT. DEVICE LOG WAS REVIEWED, SEVERAL PRESSURE SENSOR ALARMS. THE DEVICE WAS RECEIVED IN LAKE ZURICH FOR PREVENTIVE MAINTENANCE DURING WHICH OUR LOCAL TECHNICAL TEAM FOUND A FAILURE OF THE CALIBRATION OF THE DOWNSTREAM PRESSURE SENSOR. THE REPORTED DEVICES WERE NOT SENT BACK TO BRÉZINS FOR INVESTIGATION AS REPAIRS WERE PERFORMED LOCALLY. ACCORDING TO PROVIDED INFORMATION, THE CALIBRATION OF DOWNSTREAM PRESSURE SENSOR FAILED. AFTER THE REPLACEMENT OF THE PRESSURE SENSOR, THE CPU BOARD FOUND INOPERATIVE. THEREFORE, THE DOWNSTREAM PRESSURE SENSOR WAS REPLACED AND SENT BACK TO BRÉZINS FOR FURTHER INVESTIGATION. ONCE IN BRÉZINS, A VISUAL CONTROL WAS PERFORMED AND NOTHING WAS NOTICED. FOLLOWING VISUAL INSPECTION, CROSS-TESTS WERE PERFORMED. THE DOWNSTREAM PRESSURE SENSOR WAS INSTALLED IN A TEST DEVICE. THE TESTS DEVICE IS CONNECTED TO PARTNER SOFTWARE TO CALIBRATE THE PRESSURE SENSOR. AFTER VALIDATING STEP 1, NOTHING IS DISPLAYED ON THE SCREEN, THEN ERROR 42 TRIGGERED. THE REPORTED EVENT IS CONSIDERED AS VALID, AND THE ROOT CAUSE IS LIKELY DUE TO A DEFECTIVE DOWNSTREAM PRESSURE SENSOR. TO OUR KNOWLEDGE THI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23694432 ↗MalfunctionAug 12, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: CUSTOMER REPORTED ERROR 41-0002. REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE NOT REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION. DEVICE HISTORY RECORD WAS REVIEWED AND NOTHING WAS FOUND RELATED TO THE REPORTED EVENT. DEVICE LOG HISTORY WAS NOT PROVIDED THEREFORE NO REVIEW COULD BE PERFORMED. THE REPORTED DEVICE WAS NOT RETURNED TO LAKE ZURICH NOR BRÉZINS FOR INVESTIGATION. ACCORDING TO LOCAL PROTOCOL, IF AFTER 15 DAYS THE DEVICE STILL HASN'T BEEN RETURNED, THE SERVICE ORDER IS CLOSED TO NO DEVICE. SO, WE DID NOT RECEIVE ANYTHING THAT WOULD ALLOW US TO IDENTIFY THE ACTUAL ROOT CAUSE OF THIS EVENT / TO GO FURTHER WITH THIS INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. HOWEVER, IF FURTHER INFORMATION ARE PROVIDED LATER ON, WE MAY RE-OPEN THE COMPLAINT AND PURSUE ITS. TO OUR KNOWLEDGE THIS COMPLAINT IS NOT BEING RELATED TO PATIENT SAFETY. THIS COMPLAINT IS CONSIDERED AS: NOT INVESTIGATED. THE TREND IS: NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22784408 ↗MalfunctionAug 12, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: CUSTOMER REPORTED ERROR 41-0002 REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE NOT REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION. DEVICE HISTORY RECORD WAS REVIEWED AND NOTHING WAS FOUND RELATED TO THE REPORTED EVENT. DEVICE LOG HISTORY WAS NOT PROVIDED THEREFORE NO REVIEW COULD BE PERFORMED. THE REPORTED DEVICE WAS NOT RETURNED TO LAKE ZURICH NOR BRÉZINS FOR INVESTIGATION. ACCORDING TO LOCAL PROTOCOL, IF AFTER 15 DAYS THE DEVICE STILL HASN'T BEEN RETURNED, THE SERVICE ORDER IS CLOSED TO NO DEVICE. SO, WE DID NOT RECEIVE ANYTHING THAT WOULD ALLOW US TO IDENTIFY THE ACTUAL ROOT CAUSE OF THIS EVENT / TO GO FURTHER WITH THIS INVESTIGATION. THEREFORE THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. HOWEVER, IF FURTHER INFORMATION ARE PROVIDED LATER ON WE MAY RE-OPEN THE COMPLAINT AND PURSUE ITS. TO OUR KNOWLEDGE THIS COMPLAINT IS NOT BEING RELATED TO PATIENT SAFETY THIS COMPLAINT IS CONSIDERED AS: NOT INVESTIGATED THE TREND IS: NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22784403 ↗
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- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls4 deaths21,956 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths15,547 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion3 recalls6 deaths13,022 reports
- CADD 21-6500-51Icu Medical, Inc. · Pump, infusion2 deaths8,231 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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