VOLUMAT MC AGILIA US Z021135Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 04086000851794), received between Jun 21, 2024 and Sep 28, 2026 — classified as 2 deaths, 1 injury, 99 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (K121613); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026No Apparent Adverse Event

  The following has been reported:Unit does not power oncustomer sent in the attached request form reporting unit not power on.Reporting as a conservative measure. No Adverse Event effects were reported.The device was repaired by the customer; Fresenius Kabi is communicating the investigation and repair results here. Fresenius Kabi will not be receiving the device or the parts back for investigationAs this device was manufactured greater than 3 years ago (Manufacturing date: May 2015), preventative maintenance (PM) is expected to have been performed as per the device's approved maintenance schedule. Therefore, the device would have undergone two quality verifications of each essential performance parameter (at release and first PM), indicating the likelihood of a manufacturing-related issue is remote. Review of the Device History Record (DHR) has been deemed not required in accordance with internal procedure.Device history log was reviewed. Several Technical errors (37 and 38) related to the reported event were found.The reported device was received in Lake Zurich and its investigation was performed by our Local Technical Team.According to provided information, external inspection co

  Patient problems: Localized Skin Lesion

  MAUDE report 50919129 ↗
• MalfunctionSep 28, 2026No Apparent Adverse Event

  Patient problems: Localized Skin Lesion

  MAUDE report 50919128 ↗
• MalfunctionAug 26, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50460992 ↗
• MalfunctionAug 26, 2026No Apparent Adverse Event

  The following has been reported:Pump failed mid infusion with the error code "error 01(0001)".The customer ended up switching out the old pump with a new pump for their patient and are returned the defective pump.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 50460988 ↗
• MalfunctionAug 3, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50117623 ↗
• MalfunctionAug 3, 2026No Apparent Adverse Event

  The following has been reported by Customer:The Air Sensor failed during pre testing / inspection.Reporting as a conservative measure. Adverse effects were not reported.Device History Record was not reviewed as the device has already gone through its first preventive maintenance.The Device Log was reviewed, no error or issue linked to the reported event was found.The device was received in Lake Zurich for Preventive Maintenance during which our Local Technical Team found the failure of the air sensor.According to provided information, nothing was noticed during both external and internal check.The test 14 (Air sensor) failed.The air sensor has been replaced to solved the issues. The problem of defective air sensors is a known topic. An investigation is underway through an internal CAPA in order to find all possible root causes and correct them. When the sample will be received, it will be made available to the technical team to increase the test samples if necessary. Therefore this complaint is considered as VALID and the root cause is linked to a defective air sensor.To our knowledge this complaint is not being related to patient safetyThis complaint is considered as: VALID.The

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50117610 ↗
• MalfunctionJun 30, 2026No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: CUSTOMER REPORTS THAT THIS IS A NEWLY UNBOXED UNIT THAT THEY TESTED AND IT THROWS THEM ERROR CODE 49 WHILE PERFORMING THE PM. REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE NOT REPORTED. DEVICE HISTORY RECORD WAS NOT REVIEWED AS THE DEVICE HAS ALREADY GONE THROUGH ITS FIRST PREVENTIVE MAINTENANCE. 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 20 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 25667983 ↗
• MalfunctionJun 30, 2026No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: CUSTOMER REPORTS THAT THIS IS A NEWLY UNBOXED UNIT THAT THEY TESTED AND IT THROWS THEM ERROR CODE 49 WHILE PERFORMING THE PM. REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE NOT REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION. DEVICE HISTORY RECORD WAS NOT REVIEWED AS THE DEVICE HAS ALREADY GONE THROUGH ITS FIRST PREVENTIVE MAINTENANCE. 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 20 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 25667981 ↗
• MalfunctionJun 30, 2026No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: CUSTOMER REPORTS THAT THIS IS A NEWLY UNBOXED UNIT THAT THEY TESTED AND IT THROWS THEM ERROR CODE 49 WHILE PERFORMING THE PM. REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE NOT REPORTED. DEVICE HISTORY RECORD WAS NOT REVIEWED AS THE DEVICE HAS ALREADY GONE THROUGH ITS FIRST PREVENTIVE MAINTENANCE. 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 20 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 25667978 ↗
• MalfunctionJun 30, 2026No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: CUSTOMER REPORTS THAT THIS IS A NEWLY UNBOXED UNIT THAT THEY TESTED AND IT THROWS THEM ERROR CODE 49 WHILE PERFORMING THE PM. REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE NOT REPORTED. DEVICE HISTORY RECORD WAS NOT REVIEWED AS THE DEVICE HAS ALREADY GONE THROUGH ITS FIRST PREVENTIVE MAINTENANCE. 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 20 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 25667977 ↗
• MalfunctionJun 5, 2026No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: ERROR 37 - CAN'T OPERATE PUMP CUSTOMER SENT IN THE REQUEST FORM REPORTING: ERROR 37 - CAN'T OPERATE PUMP. REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE NOT REPORTED. DEVICE HISTORY RECORD WAS NOT REVIEWED AS THE DEVICE HAS ALREADY GONE THROUGH ITS FIRST PREVENTIVE MAINTENANCE. DEVICE HISTORY LOG WAS REVIEWED. SEVERAL TECHNICAL ERRORS 37 RELATED TO THE REPORTED EVENT WERE FOUND. THE REPORTED DEVICE WAS RECEIVED IN LAKE ZURICH AND ITS INVESTIGATION WAS PERFORMED BY OUR LOCAL TECHNICAL TEAM. ACCORDING TO PROVIDED INFORMATION, THE REPORTED EVENT WAS NOT REPRODUCED BUT EXTERNAL INSPECTION FOUND DELAMINATED START/ OK BUTTON THAT COULD FIRMED THE REPORTED EVENT. DURING TESTS, OCS TEST FAILED (MISSING RIBBON CABLE Z179413). INTERNAL INSPECTION FOUND THAT RIBBON CABLE FROM CPU BOARD TO POWER SUPPLY BOARD IS MISSING LIKELY DUE TO A MISHANDLING OF THE DEVICE. THIS COMPLAINT REGARDING THE ERROR 37 IS CONSIDERED AS VALID, LINKED TO AN AGEING OF THE KEYPAD. TO OUR KNOWLEDGE THIS COMPLAINT IS NOT BEING RELATED TO PATIENT SAFETY. THIS COMPLAINT IS CONSIDERED AS: VALID. THE TREND IS: NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25408798 ↗
• MalfunctionJun 5, 2026No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: ERROR 37 - CAN'T OPERATE PUMP CUSTOMER SENT IN THE REQUEST FORM REPORTING: ERROR 37 - CAN'T OPERATE PUMP. REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE NOT REPORTED. DEVICE HISTORY RECORD WAS NOT REVIEWED AS THE DEVICE HAS ALREADY GONE THROUGH ITS FIRST PREVENTIVE MAINTENANCE. DEVICE HISTORY LOG WAS REVIEWED. SEVERAL TECHNICAL ERRORS 37 RELATED TO THE REPORTED EVENT WERE FOUND. THE REPORTED DEVICE WAS RECEIVED IN LAKE ZURICH AND ITS INVESTIGATION WAS PERFORMED BY OUR LOCAL TECHNICAL TEAM. ACCORDING TO PROVIDED INFORMATION, THE REPORTED EVENT WAS NOT REPRODUCED BUT EXTERNAL INSPECTION FOUND DELAMINATED START/ OK BUTTON THAT COULD FIRMED THE REPORTED EVENT. DURING TESTS, OCS TEST FAILED (MISSING RIBBON CABLE Z179413). INTERNAL INSPECTION FOUND THAT RIBBON CABLE FROM CPU BOARD TO POWER SUPPLY BOARD IS MISSING LIKELY DUE TO A MISHANDLING OF THE DEVICE. THIS COMPLAINT REGARDING THE ERROR 37 IS CONSIDERED AS VALID, LINKED TO AN AGEING OF THE KEYPAD. TO OUR KNOWLEDGE THIS COMPLAINT IS NOT BEING RELATED TO PATIENT SAFETY THIS COMPLAINT IS CONSIDERED AS: VALID THE TREND IS: NORMAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25408794 ↗
• MalfunctionJun 3, 2026No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: DAMAGE TO FRONT LOCKING MECHANISM CUSTOMER SENT IN THE REQUEST FORM REPORTING: DAMAGE TO FRONT LOCKING MECHANISM FOR TUBING. ACTION TAKEN: RECEIVED PUMP (B)(6). CONFIRMED CUSTOMER REPORTED ISSUE. THE DOOR LOCKING MECHANISM WAS FOUND TO BE DAMAGED, AND THE DOOR ASSEMBLY WAS REPLACED. ADDITIONALLY, THE LCD DISPLAY BACKLIGHT WAS INOPERATIVE; AS A RESULT, THE DISPLAY WAS REPLACED. THE AIR SENSOR FAILED CALIBRATION AND WAS ALSO REPLACED. A FULL CALIBRATION WAS PERFORMED ON THE DEVICE. EQUIPMENT CLEANED, POST SERVICE TESTED AND RELEASED FOR USE. REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE NOT REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION. DEVICE HISTORY RECORD WAS NOT REVIEWED AS THE DEVICE HAS ALREADY GONE THROUGH ITS FIRST PREVENTIVE MAINTENANCE. DEVICE LOG WAS REVIEWED, NO ERROR OR ISSUE LINKED TO THE REPORTED EVENT WAS FOUND. THE REPORTED DEVICE WAS RECEIVED IN LAKE ZURICH AND ITS INVESTIGATION WAS PERFORMED BY OUR LOCAL TECHNICAL TEAM. DURING THIS INVESTIGATION, THE SCREEN WAS FOUND VERY DIM, BACK LIGHT WAS NOT FUNCTIONING. THIS COMPLAINT IS CONSIDERED AS VALID, DIM SCREEN IS DUE TO AGEING, DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375229 ↗
• MalfunctionJun 3, 2026No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: DAMAGE TO FRONT LOCKING MECHANISM CUSTOMER SENT IN THE REQUEST FORM REPORTING: DAMAGE TO FRONT LOCKING MECHANISM FOR TUBING. ACTION TAKEN: RECEIVED PUMP (B)(6). CONFIRMED CUSTOMER REPORTED ISSUE. THE DOOR LOCKING MECHANISM WAS FOUND TO BE DAMAGED, AND THE DOOR ASSEMBLY WAS REPLACED. ADDITIONALLY, THE LCD DISPLAY BACKLIGHT WAS INOPERATIVE; AS A RESULT, THE DISPLAY WAS REPLACED. THE AIR SENSOR FAILED CALIBRATION AND WAS ALSO REPLACED. A FULL CALIBRATION WAS PERFORMED ON THE DEVICE. EQUIPMENT CLEANED, POST SERVICE TESTED AND RELEASED FOR USE. REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE NOT REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION. DEVICE HISTORY RECORD WAS NOT REVIEWED AS THE DEVICE HAS ALREADY GONE THROUGH ITS FIRST PREVENTIVE MAINTENANCE. DEVICE LOG WAS REVIEWED, NO ERROR OR ISSUE LINKED TO THE REPORTED EVENT WAS FOUND. THE REPORTED DEVICE WAS RECEIVED IN LAKE ZURICH AND ITS INVESTIGATION WAS PERFORMED BY OUR LOCAL TECHNICAL TEAM. DURING THIS INVESTIGATION, THE SCREEN WAS FOUND VERY DIM, BACK LIGHT WAS NOT FUNCTIONING. THIS COMPLAINT IS CONSIDERED AS VALID, DIM SCREEN IS DUE TO AGEING, DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375227 ↗
• MalfunctionApr 28, 2026No Apparent Adverse Event; Air/Gas in Device

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: CUSTOMER SENT IN THE REQUEST FORMS REPORTING: AIR IN LINE ERROR. 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 25019761 ↗
• MalfunctionApr 28, 2026No Apparent Adverse Event; Air/Gas in Device

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: CUSTOMER SENT IN THE REQUEST FORMS REPORTING: AIR IN LINE ERROR. 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 25019737 ↗
• MalfunctionApr 28, 2026No Apparent Adverse Event; Air/Gas in Device

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: CUSTOMER SENT IN THE REQUEST FORMS REPORTING: AIR IN LINE ERROR. 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 25019713 ↗
• MalfunctionApr 28, 2026No Apparent Adverse Event; Air/Gas in Device

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: CUSTOMER SENT IN THE REQUEST FORMS REPORTING: AIR IN LINE ERROR. 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 25019646 ↗
• MalfunctionApr 13, 2026No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: AIR IN LINE ERROR: CUSTOMER REPORTING AIR IN LINE ERROR-REPORTED TRYING TO CLEAR SEVERAL TIMES AND ERROR WOULD NOT CLEAR. REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE NOT REPORTED. DEVICE HISTORY RECORD WAS REVIEWED AND NOTHING WAS FOUND RELATED TO THE REPORTED EVENT. THE DEVICE LOG WAS REVIEWED, NO ERROR OR ISSUE LINKED TO THE REPORTED EVENT WAS FOUND. THE REPORTED DEVICE WAS RECEIVED IN LAKE ZURICH AND ITS INVESTIGATION WAS PERFORMED BY OUR LOCAL TECHNICAL TEAM. ACCORDING TO PROVIDED INFORMATION, NOTHING WAS NOTICED DURING BOTH EXTERNAL AND INTERNAL CHECK. DURING TESTS, DEVICE REPORTS AIR BUBBLE WHEN TUBE WITH WATER IS INSTALLED. CALIBRATION OF THE AIR SENSOR RESOLVED THE ISSUE. THIS COMPLAINT WILL BE CONSIDERED AS A VALID, THE ROOT CAUSE IS LIKELY DUE TO DRIFT OF VALUE, SO AIR CALIBRATION NEEDED. PLEASE BE INFORMED THAT AN INTERNAL CAPA WAS OPENED FOR DEFECTIVE AIR SENSORS, IN PARTICULAR A DRIFT OF THE SENSORS. TO OUR KNOWLEDGE THIS COMPLAINT IS NOT BEING RELATED TO PATIENT SAFETY. THIS COMPLAINT IS CONSIDERED AS: VALID. THE TREND IS: NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865173 ↗
• MalfunctionApr 13, 2026No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: INTERNAL COMPONENT LOOSE AND RATTLING CUSTOMER SENT IN THE FORM REPORTING THE INTERNAL COMPONENT LOOSE AND RATTLING (LOOSE SCREW). 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 24865154 ↗
• MalfunctionApr 13, 2026No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: AIR IN LINE ERROR CUSTOMER REPORTING AIR IN LINE ERROR-REPORTED TRYING TO CLEAR SEVERAL TIMES AND ERROR WOULD NOT CLEAR. REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE NOT REPORTED. DEVICE HISTORY RECORD WAS REVIEWED AND NOTHING WAS FOUND RELATED TO THE REPORTED EVENT. THE DEVICE LOG WAS REVIEWED, NO ERROR OR ISSUE LINKED TO THE REPORTED EVENT WAS FOUND. THE REPORTED DEVICE WAS RECEIVED IN LAKE ZURICH AND ITS INVESTIGATION WAS PERFORMED BY OUR LOCAL TECHNICAL TEAM. ACCORDING TO PROVIDED INFORMATION, NOTHING WAS NOTICED DURING BOTH EXTERNAL AND INTERNAL CHECK. DURING TESTS, DEVICE REPORTS AIR BUBBLE WHEN TUBE WITH WATER IS INSTALLED. CALIBRATION OF THE AIR SENSOR RESOLVED THE ISSUE. THIS COMPLAINT WILL BE CONSIDERED AS A VALID, THE ROOT CAUSE IS LIKELY DUE TO DRIFT OF VALUE, SO AIR CALIBRATION NEEDED. PLEASE BE INFORMED THAT AN INTERNAL CAPA WAS OPENED FOR DEFECTIVE AIR SENSORS, IN PARTICULAR A DRIFT OF THE SENSORS. TO OUR KNOWLEDGE THIS COMPLAINT IS NOT BEING RELATED TO PATIENT SAFETY THIS COMPLAINT IS CONSIDERED AS: VALID THE TREND IS: NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24864211 ↗
• MalfunctionApr 13, 2026No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: INTERNAL COMPONENT LOOSE AND RATTLING CUSTOMER SENT IN THE FORM REPORTING THE INTERNAL COMPONENT LOOSE AND RATTLING (LOOSE SCREW). 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 24863972 ↗
• MalfunctionFeb 5, 2026No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: AIR ERROR: CUSTOMER EMAILED IN THE REQUEST FORM REPORTING: CANNOT OPERATE PUMP. CONTINUES TO GIVE AIR ERROR. EVEN THOUGH WE HAVE VISUALIZED NO AIR IS PRESENT IN THE LINE. 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 24272241 ↗
• MalfunctionFeb 5, 2026No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: AIR ERROR: CUSTOMER EMAILED IN THE REQUEST FORM REPORTING: CANNOT OPERATE PUMP. CONTINUES TO GIVE AIR ERROR. EVEN THOUGH WE HAVE VISUALIZED NO AIR IS PRESENT IN THE LINE. 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 24272206 ↗
• MalfunctionJan 30, 2026Excess Flow or Over-Infusion; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED BY CUSTOMER: PUMP INFUSED MEDICATION AT FAST RATE. CUSTOMER EMAILED IN THE REQUEST FORM REPORTING: PUMP INFUSED MEDICATION AT RATE FASTER THAN IT WAS PROGRAMMED FOR. 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 24220856 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121613. One submission often covers many models, so check the product and lot details in each record.

• Z-2064-2019 · Jun 24, 2019 · Terminated
  VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to
• Z-0362-2019 · Dec 2, 2017 · Terminated
  Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to