Nimbus II PlusRecalls & reported problems

Summary

The FDA's MAUDE database contains 800 adverse event reports that list this exact device (DI 00817170020161), received between Dec 3, 2020 and Aug 9, 2024 — classified as 1 death, 799 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (372 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 800 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2024Power Problem; Power Problem

  INFUTRONIX RECEIVED A REPORT THAT THE PATIENT EXPERIENCED A POWER OFF AND CALLED SUPPORT TO ATTEMPT TO RESUME INFUSION. THERE WAS NO HARM TO THE PATIENT. NO FURTHER DETAILS WERE PROVIDED. THE MEDICATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19956727 ↗
• MalfunctionAug 9, 2024Power Problem; Intermittent Loss of Power; Power Problem; Intermittent Loss of Power

  INFUTRONIX RECEIVED A REPORT THAT THE PATIENT EXPERIENCED A POWER OFF MULTIPLE TIMES DURING USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19956555 ↗
• MalfunctionAug 9, 2024Power Problem; Power Problem

  INFUTRONIX RECEIVED A REPORT THAT THE PATIENT EXPERIENCED A POWER OFF DURING USE. THERE WAS NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19956287 ↗
• MalfunctionAug 9, 2024Power Problem; Power Problem

  INFUTRONIX RECEIVED A REPORT THAT THE PATIENT EXPERIENCED A POWER OFF DURING USE. THERE WAS NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19955727 ↗
• MalfunctionAug 9, 2024Power Problem; Power Problem

  INFUTRONIX RECEIVED A REPORT THAT THE PATIENT EXPERIENCED A POWER OFF DURING USE. THERE WAS NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19952899 ↗
• MalfunctionJul 12, 2024Mechanical Problem; Mechanical Problem

  INFUTRONIX RECEIVED A REPORT THAT THE PUMP HAD AN IMMEDIATE POWER OFF. THERE WERE NO OTHER DETAILS PROVIDED. THE EXACT DATE OF THE EVENT WAS NOT PROVIDED. THERE WAS NO PATIENT INJURY REPORTED. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION WERE MADE, INCLUDING A REQUEST TO RETURN THE PUMP FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19736111 ↗
• MalfunctionJul 12, 2024Mechanical Problem; Mechanical Problem

  INFUTRONIX RECEIVED A REPORT THAT THE PUMP HAD AN IMMEDIATE POWER OFF. THERE WERE NO OTHER DETAILS PROVIDED. THE EXACT DATE OF THE EVENT WAS NOT PROVIDED. THERE WAS NO PATIENT INJURY REPORTED. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION WERE MADE, INCLUDING A REQUEST TO RETURN THE PUMP FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19736023 ↗
• MalfunctionJul 12, 2024Mechanical Problem; Mechanical Problem

  INFUTRONIX RECEIVED A REPORT THAT THE PUMP HAD AN IMMEDIATE POWER OFF. THERE WERE NO OTHER DETAILS PROVIDED. THE EXACT DATE OF THE EVENT WAS NOT PROVIDED. THERE WAS NO PATIENT INJURY REPORTED. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION WERE MADE, INCLUDING A REQUEST TO RETURN THE PUMP FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735923 ↗
• MalfunctionJul 12, 2024Mechanical Problem; Mechanical Problem

  INFUTRONIX RECEIVED A REPORT THAT THE PUMP HAD AN IMMEDIATE POWER OFF. THERE WERE NO OTHER DETAILS PROVIDED. THE EXACT DATE OF THE EVENT WAS NOT PROVIDED. THERE WAS NO PATIENT INJURY REPORTED. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION WERE MADE, INCLUDING A REQUEST TO RETURN THE PUMP FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735790 ↗
• MalfunctionJul 12, 2024Mechanical Problem; Mechanical Problem

  INFUTRONIX RECEIVED A REPORT THAT THE PUMP HAD AN IMMEDIATE POWER OFF. THERE WERE NO OTHER DETAILS PROVIDED. THE EXACT DATE OF THE EVENT WAS NOT PROVIDED. THERE WAS NO PATIENT INJURY REPORTED. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION WERE MADE, INCLUDING A REQUEST TO RETURN THE PUMP FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735584 ↗
• MalfunctionJul 2, 2024Complete Loss of Power; Complete Loss of Power

  ON 06/07/2024, IT WAS REPORTED THAT MULTIPLE PUMPS HAD AN ABRUPT POWER OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656118 ↗
• MalfunctionJul 2, 2024Complete Loss of Power; Complete Loss of Power

  ON 06/07/2024, IT WAS REPORTED THAT MULTIPLE PUMPS HAD AN ABRUPT POWER OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656072 ↗
• MalfunctionJun 26, 2024Power Problem; Complete Loss of Power; Power Problem; Complete Loss of Power

  ON 06/06/2024, INFUTRONIX RECEIVED A REPORT FROM THE PATIENT STATING THEY WOKE TO A BLANK SCREEN. PATIENT STATED SHE WENT TO THE CLINIC AND THEY REPROGRAMMED HER PUMP AND SENT HER ON HER WAY (NO BATTERY WAS REPLACED THAT SHE IS AWARE OF). PATIENT IS CALLING BECAUSE THE PUMP DIED AGAIN. TECH SUPPORT ATTEMPTED POWERING IT BACK UP ONLY TO FIND NEW INFUSION ONLY...THE PUMP HAS LOST ALL ITS INFUSION PARAMETERS. PATIENT WAS INSTRUCTED TO POWER THE UNIT BACK OFF AND CLAMPED THE LINE. TECH SUPPORTED INSTRUCTED THE PATIENT TO GO TO HER INFUSION CENTER TO GET THE PUMP REPLACED. NO PATIENT INJURY/HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19619637 ↗
• MalfunctionJun 26, 2024Power Problem; Complete Loss of Power; Power Problem; Complete Loss of Power

  ON (B)(6) 2024, INFUTRONIX RECEIVED A COMPLAINT STATING THAT THE PUMP HAD SHUT OFF AND PER COMPLETED RECALL RETURN FORM PUMP RETURNED. THERE WERE NO OTHER DETAILS PROVIDED. NO PATIENT INVOLVED INJURED/HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19614737 ↗
• MalfunctionJun 25, 2024Power Problem; Complete Loss of Power; Power Problem; Complete Loss of Power

  ON 01/04/2024, INFUTRONIX RECEIVED A REPORT FROM THE CUSTOMER REPORTING THAT AFTER MUCH TROUBLESHOOTING THE PUMP CONTINUED TO TURN OFF AND WAS CONSTANTLY BEEPING CAN WE SEND HER A NEW PUMP PLEASE. NO PATIENT INJURY/HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610234 ↗
• MalfunctionJun 17, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  ON 06/06/2023, INFUTRONIX RECEIVED A REPORT THAT THE PUMP KEPT SHUTTING OFF. THERE WAS NO PATIENT INJURY REPORTED. SUBSEQUENT INFORMATION RECEIVED ON 06/07/2023 INDICATED THE MEDICATION TO BE INFUSED WAS FLUOROURACIL AT A VOLUME OF 92ML. HOWEVER, THERE WAS A DELAY IN THERAPY SINCE THE PUMP WOULD AUTOMATICALLY SHUT OFF WITHOUT AN AUDIBLE SOUND OR VISIBLE ERROR MESSAGE, AND THE INFUSION COULD NOT BE STARTED. THE PUMP IN QUESTION WAS SET ASIDE, AND THE THERAPY WAS SUCCESSFULLY ADMINISTERED WITH ANOTHER PUMP. THE PUMP IN QUESTION WAS NOT AVAILABLE FOR RETURN AT THE INITIAL TIME THAT THE EVENT WAS REPORTED, AND THE COMPLAINT FILE WAS CLOSED. ON 05/17/2024, THE PUMP WAS RETURNED TO INFUTRONIX FOR EVALUATION WITH REFERENCE TO THIS EVENT. THE REPORTABILITY DECISION WAS RE-EVALUATED AND DETERMINED TO BE 30-DAY REPORTABLE TO FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548226 ↗
• MalfunctionJun 14, 2024Power Problem; Complete Loss of Power; Power Problem; Complete Loss of Power

  ON 02/12/2024, INFUTRONIX RECEIVED A REPORT FROM THE PATIENT STATING THAT UPON WAKING UP THE PUMP WAS COVERED IN ZOFRAN AND HAD POWERED OFF ON ITS OWN. THE PATIENT STATED THEY WERE NOT SURE WHERE THE LEAK HAD CAME FROM AS THEY STATED THE SYRINGE WAS ON TIGHTLY. PATIENT WAS UNABLE TO TURN THE PUMP BACK ON, DELAYING THEM IN GETTING TREATMENT. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19543476 ↗
• MalfunctionJun 14, 2024Failure to Infuse; Power Problem; Failure to Infuse; Power Problem

  DURING PRODUCT EVALUATION ON JUNE 6, 2024, IT WAS DETERMINED THAT DEVICE ABRUPTLY POWER ITSELF OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538169 ↗
• MalfunctionJun 14, 2024Failure to Infuse; Power Problem; Failure to Infuse; Power Problem

  IT WAS REPORTED THAT PATIENT'S PUMP POWER ITSELF OFF. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536584 ↗
• MalfunctionJun 12, 2024Failure to Infuse; Power Problem; Failure to Infuse; Power Problem

  DURING PRODUCT EVALUATION ON JUNE 6, 2024, IT WAS DETERMINED THAT DEVICE ABRUPTLY POWER ITSELF OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525484 ↗
• MalfunctionJun 3, 2024Failure to Power Up; Failure to Power Up

  ON 10/02/2024, INFUTRONIX MEDICAL RECEIVED A REPORT FROM THE CUSTOMER REPORTING THAT PUMP #(B)(4) KEPT TURNING ITSELF OFF. THE PUMP WAS RECEIVED ON 11/9/2023., WHICH THE COMPLAINT HAD BEEN DEEMED AS NON REPORTABLE EVENT AT THAT TIME. THE MDR REPORTABILITY OF THE COMPLAINT HAS BEEN UPGRADED TO "YES" DUE TO PROTOCOL 6. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448611 ↗
• MalfunctionJun 3, 2024Power Problem; Complete Loss of Power; Power Problem; Complete Loss of Power

  05/09/2024, INFUTRONIX MEDICAL RECEIVED A REPORT FROM A PATIENT STATING HIS PUMP WAS NOT WORKING AT ALL AS THE SCREEN WAS NOT SHOWING THE NUMBERS OR ANYTHING. THE PATIENT MENTIONED IT HAD BEEP EARLIER BEFORE CALLING, BUT HAD NO IDEA WHAT THE ALERT MIGHT HAVE BEEN. TECH SUPPORT HAD THE PATIENT LOOK AT THE SCREENIT AND IT WAS CONFIRMED THE PATIENT WAS IN THE TRIATION MENU THE PUMP HAD BEEN PAUSED AND NOT RUNNING THE INFUSION. THE TECH SUPPORT ASSISTED THE PATIENT TO RESTART THE PUMP AND RESUME THE INFUSION WITHOUT FURTHER ISSUES. NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447971 ↗
• MalfunctionMay 24, 2024Power Problem; Complete Loss of Power; Power Problem; Complete Loss of Power

  ON 05/08/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD POWER ISSUE - DEVICE POWERS SELF OFF. THE COMPLAINT WILL BE 14 OF 14 FOR IMMEDIATE POWER OFF EVENT. NO PATIENT WAS INVOLVED. DEVICE WAS REQUESTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393662 ↗
• MalfunctionMay 24, 2024Power Problem; Complete Loss of Power; Power Problem; Complete Loss of Power

  ON 05/08/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD POWER ISSUE - DEVICE POWERS SELF OFF. NO PATIENT WAS INVOLVED. DEVICE WAS REQUESTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392392 ↗
• MalfunctionMay 22, 2024Complete Loss of Power; Complete Loss of Power

  PUMP WAS RETURNED ON 5/10/2024 AND EVALUATED. THE MDR REPORTABILITY OF THIS COMPLAINT WAS BEING UPGRADED TO "YES", AS THE ABRUPT POWER OFF FOUND IN THE EVENT LOG REVIEW WAS DETERMINED TO BE REPORTABLE ACCORDING TO THE UPDATED MDR DECISION TREE GUIDE. PATIENT WAS INVOLVED, BUT NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19376110 ↗

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.