Nimbus II FlexRecalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 00817170020093), received between Feb 21, 2018 and May 24, 2024 — classified as 1 death, 130 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (49 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K153193); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 21, 2024Open, Classified

   InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing. The device will not be available or supported after June 20, 2024.

   Z-1286-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 131 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2024Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem

  ON 04/24/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD A FLOW RATE ISSUE - USER REPORTS FLOW RATE ISSUE. BUT THE FLOW RATE ACCURACY WAS UNKNOWN. THE PUMP WAS ALLEGEDLY WAS HAVING TREATMENT BUT DID NOT INFUSE COMPLETELY. NO PATIENT WAS NOT HARMED. DEVICE WAS REQUESTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391469 ↗
• MalfunctionMay 21, 2024Mechanical Problem; Infusion or Flow Problem; No Flow; Mechanical Problem; Infusion or Flow Problem; No Flow

  ON 06-JUN-2024, INFUTRONIX RECEIVED THE PUMP WHICH WAS PREVIOUSLY REQUESTED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19363502 ↗
• MalfunctionMay 19, 2024Mechanical Problem; Infusion or Flow Problem; No Flow; Mechanical Problem; Infusion or Flow Problem; No Flow

  ON 04/24/2024, INTUVIE RECEIVED A REPORT VIA EMAIL FROM THE CUSTOMER REPORTING A "SYSTEM FAILURE" ALERT ON THE PUMP. THE PUMP WAS RECEIVED ON 5/3/2024. THE PUMP HAD A COMPLAINT FORM ATTACHED TO IT, WHICH UPDATED THE EVENT DATE TO 3/25/2024, THE DESCRIPTION OF THE EVENT STATES, "WHEN TURNED ON TO CONNECT PATIENT IT SAID SYSTEM FAILURE". THERE WAS NO PATIENT HARM DURING THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19348725 ↗
• MalfunctionMay 8, 2024Mechanical Problem; Failure to Deliver; Mechanical Problem; Failure to Deliver

  ON 01/31/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP STOPPED INFUSING DUE TO A SYSTEM ERROR ALERT. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. NO PATIENT INJURY. DEVICE WAS RETURNED ON 02/20/2024. DETAIL OF THE EVALUATION WAS IN SECTION H OF THIS MDR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267635 ↗
• MalfunctionMay 3, 2024Device Alarm System; Mechanical Problem; Device Sensing Problem; Infusion or Flow Problem; Device Alarm System; Mechanical Problem; Device Sensing Problem; Infusion or Flow Problem

  THIS CORRECTION IS BEING FILED TO UPDATE SECTION H11 IN THE INITIAL FILING: THE INFUSION RAN ON THE PUMP DURING THE INVESTIGATION WAS ABLE TO BE SET TO 37.8 ML AT MAXIMUM, NOT 37.2 ML. A NONCONFORMANCE IS BEING OPENED TO INVESTIGATE THE ISSUE OF THE PUMP NOT BEING ABLE TO REACH ITS LIFETIME SPECIFICATION, NOT A CAPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237437 ↗
• MalfunctionMay 1, 2024Mechanical Problem; Mechanical Problem

  ON 01/31/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP STOPPED INFUSING DUE TO A SYSTEM ERROR ALERT. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. NO PATIENT WAS INVOLVED. THE DEVICE WAS RETURNED ON 02/15/2024 FOR FURTHER EVALUATION. DETAIL OF THE EVALUATION CAN BE FOUND IN SECTION H OF THIS MDR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19225253 ↗
• MalfunctionApr 29, 2024Mechanical Problem; Failure to Deliver; Mechanical Problem; Failure to Deliver

  INFUTRONIX RECEIVED A REPORT THAT A PUMP STOPPED INFUSING DUE TO A SYSTEM ERROR ALERT. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. NO PATIENT WAS HARMED. DEVICE WAS RETURNED ON 02/22/2024 FOR FURTHER EVALUATION. SEE SECTION H OF THIS MDR FOR DETAIL OF THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19205180 ↗
• MalfunctionApr 23, 2024Complete Loss of Power; Complete Loss of Power

  ON 1-7-2021 E. CAISSE OF ZYNO SOLUTIONS RECEIVED AN EMAIL FROM L. TROPPMANN OF 678-FAIRBANKS, TROPPMANN STATED THAT PUMP (B)(6) WOULD POWER OFF EVEN AFTER A BATTERY CHANGE. DID NOT HAPPEN DURING AN INFUSION. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169586 ↗
• MalfunctionApr 23, 2024Power Problem; Complete Loss of Power; Power Problem; Complete Loss of Power

  ON 04/18/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD POWER ISSUE - DEVICE POWERS SELF OFF. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. NO PATIENT WAS HARMED. DEVICE WAS REQUESTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166482 ↗
• MalfunctionApr 19, 2024Complete Loss of Power; Complete Loss of Power

  ON (B)(6) 2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD POWER ISSUE - DEVICE POWERS SELF OFF. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. NO PATIENT HARMED. DEVICE WAS RETURNED ON (B)(6) 2024. DETAIL OF THE EVALUATION CAN BE FOUND IN SECTION H OF THIS MDR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143952 ↗
• MalfunctionApr 15, 2024Device Alarm System; Device Sensing Problem; Complete Loss of Power; Device Alarm System; Device Sensing Problem; Complete Loss of Power

  ON (B)(6) 2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD AN "UNKNOWN ISSUE - UNKNOWN ISSUE FROM CUSTOMER". THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. NO PATIENT WAS INVOLVED AND HARMED. DEVICE WAS RETURNED ON 01/24/2024. DETAIL OF THE EVALUATION CAN BE FOUND IN SECTION H OF THIS MDR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19112276 ↗
• MalfunctionApr 11, 2024Problem with Software Installation; Problem with Software Installation

  ON (B)(6) 2020 A COMPLAINT WAS OPENED IN QOS WHERE INTUVIE RECEIVED A COMPLAINT THAT THE PUMP HAS INCORRECT LIBRARY CONFIGURATION. THERE IS AN USER INTERFACE ISSUE WHERE AFTER TYPING IN THE CLINICIAN CODE THEY COULDN'T EDIT THE PARAMETERS AND COULDN'T START AN INFUSION. THE SCREEN JUST GOES BACK ASKING AGAIN AND AGAIN TO ENTER THE CLINICIAN CODE. NO OTHER DETAILS WERE PROVIDED ASSOCIATED WITH THE EVENT. NO PATIENT HARM WAS REPORTED IN THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094227 ↗
• MalfunctionApr 11, 2024Problem with Software Installation; Problem with Software Installation

  ON (B)(6) 2020 A COMPLAINT WAS OPENED IN QOS WHERE INTUVIE RECEIVED A COMPLAINT THAT THE PUMP HAS INCORRECT LIBRARY CONFIGURATION. THERE IS AN USER INTERFACE ISSUE WHERE AFTER TYPING IN THE CLINICIAN CODE THEY COULDN'T EDIT THE PARAMETERS AND COULDN'T START AN INFUSION. THE SCREEN JUST GOES BACK ASKING AGAIN AND AGAIN TO ENTER THE CLINICIAN CODE. NO OTHER DETAILS WERE PROVIDED ASSOCIATED WITH THE EVENT. NO PATIENT HARM WAS REPORTED IN THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094219 ↗
• MalfunctionApr 5, 2024Device Alarm System; Device Sensing Problem; Complete Loss of Power; Device Alarm System; Device Sensing Problem; Complete Loss of Power

  ON 12/08/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD 'AN UNKNOWN ISSUE FROM CUSTOMER" NO PATIENT WAS HARMED. DEVICE WAS RETURNED ON 01/29/2024 FOR EVALUATION. DETAIL OF THE EVALUATION CAN BE FOUND IN SECTION H OF THIS MDR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19053616 ↗
• MalfunctionMar 28, 2024Mechanical Problem; Infusion or Flow Problem; Complete Loss of Power; Mechanical Problem; Infusion or Flow Problem; Complete Loss of Power

  ON 03/22/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP POWERED OFF ON ITS OWN WITHOUT WARNING, CAUSING LOSS OF INFUSION PARAMETERS. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. NO PATIENT HARMED. REQUESTED DEVICE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18999391 ↗
• MalfunctionMar 22, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  ON 06-JUN-2024, INFUTRONIX RECEIVED THE PUMP WHICH WAS PREVIOUSLY REQUESTED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965143 ↗
• MalfunctionMar 14, 2024Pressure Problem; Complete Loss of Power; Pressure Problem; Complete Loss of Power

  ON 01/31/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD " OCCLUSION SENSOR- CONSTANT NUISANCE ALARM". THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. THE PUMP WAS RECEIVED ON 2/20/2024 AND TESTED ON 3/8/2024. ISSUES OF UPSTREAM OCCLUSION AND ABRUPT POWER OFF WERE FOUND, DEVICE NOT PERFORMING TO SPECIFICATION. NO PATIENT HARMED. DETAIL OF THE EVALUATION WAS IN SECTION H OF THIS MDR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18903598 ↗
• MalfunctionMar 12, 2024Complete Loss of Power; Complete Loss of Power

  ON 01/31/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP POWERED OFF ON ITS OWN WITHOUT WARNING, CAUSING LOSS OF INFUSION PARAMETERS. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. NO PATIENT HARMED. THE PUMP WAS RETURNED ON 2/20/2024 AND WAS TESTED ON 3/8/2024. DETAIL OF THE FINDINGS ARE AVAILABLE IN SECTION H OF THIS MDR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891610 ↗
• MalfunctionMar 11, 2024Insufficient Flow or Under Infusion; Complete Loss of Power; Insufficient Flow or Under Infusion; Complete Loss of Power

  INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD AN 'UNKNOWN ISSUE ". PUMP RECEIVED ON 1/24/2024 AND TESTED ON 3/4/2024. DETAIL OF THE DEVICE EVALUATION CAN BE FOUND IN SECTION H OF THIS MDR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882897 ↗
• MalfunctionMar 11, 2024Device Alarm System; Complete Loss of Power; Device Alarm System; Complete Loss of Power

  INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD AN 'UNKNOWN ISSUE ". PUMP RECEIVED ON 1/24/2024 AND TESTED ON (B)(6) 2024. DETAIL OF THE DEVICE EVALUATION CAN BE FOUND IN SECTION H OF THIS MDR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882845 ↗
• MalfunctionMar 6, 2024Electrical /Electronic Property Problem; Complete Loss of Power; Electrical /Electronic Property Problem; Complete Loss of Power

  ON 02/29/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP POWERED OFF ON ITS OWN WITHOUT WARNING, CAUSING LOSS OF INFUSION PARAMETERS. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. REQUESTED DEVICE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851962 ↗
• MalfunctionMar 6, 2024Complete Loss of Power; Complete Loss of Power

  ON 02/29/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP POWERED OFF ON ITS OWN WITHOUT WARNING, CAUSING LOSS OF INFUSION PARAMETERS. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. REQUESTED DEVICE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851791 ↗
• MalfunctionMar 5, 2024Mechanical Problem; Infusion or Flow Problem; No Flow; Mechanical Problem; Infusion or Flow Problem; No Flow

  ON (B)(6) 2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP STOPPED INFUSING DUE TO A SYSTEM ERROR ALERT. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. REQUESTED DEVICE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839578 ↗
• MalfunctionFeb 27, 2024Device Alarm System; Device Alarm System

  ON (B)(6) 2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD AN ' UP OCCLUSION SENSOR - CONSTANT NUISANCE ALARM" ISSUE CAUSING LOSS OF INFUSION PARAMETERS. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. THE PUMP WAS RECEIVED ON 2/22/2024 AND TESTED ON 2/22/2024. DETAIL OF THE FINDING CAN BE FOUND ON SECTION H10 OF THIS MDR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18787753 ↗
• MalfunctionFeb 26, 2024Complete Loss of Power; Complete Loss of Power

  THE ORIGINAL COMPLAINT HAD AN UNKNOWN ISSUE. HOWEVER, THE PUMP WAS RETURNED ON 1/24/2024 AND TESTED ON 2/23/2024. THE EVALUATION FINDING WAS STATED IN SECTION H10 OF THIS MDR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784194 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153193. One submission often covers many models, so check the product and lot details in each record.

• Z-1811-2024 · Apr 18, 2024 · Open, Classified
  Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
• Z-1285-2024 · Feb 21, 2024 · Open, Classified
  Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
• Z-0832-2022 · Oct 19, 2021 · Open, Classified
  Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP
• Z-2055-2019 · May 28, 2019 · Terminated
  Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.