Nimbus (UDI 00817170020000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00817170020000), received between Dec 13, 2017 and May 9, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (3 reports).

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

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-1285-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2019Mechanical Problem; Noise, Audible; Mechanical Problem; Noise, Audible

  INFUTRONIX RECEIVED A POWER ISSUE OF THE DEVICE FROM A USER FACILITY REPRESENTATIVE ON (B)(6) 2019 THAT "I HAVE A PUMP ON MY DESK THAT WAS RETURNED FROM ONE OF OUR FACILITIES FOR THE FOLLOWING REASONS (THEIR WORDS): WHEN THE PUMP BOLUSES THE SCREEN GOES BLANK. IT'S MAKING A SOUND THAT DOESN'T SOUND LIKE THE OTHERS - IT'S A SLOW GRINDING SOUND. WHEN THE CASSETTE IS REMOVED THE SCREEN SAYS UPSTREAM OCCLUSION INSTEAD OF CASSETTE LOADING ERROR. THE PATIENT'S BLOOD SUGAR WAS VERY HIGH THEN LOW AND IT APPEARS TO BE FROM THE PUMP NOT BOLUSING CORRECTLY. THE SERIAL # OF THE PUMP IS (B)(4)." INFUTRONIX FOLLOWED-UP WITH THIS REPRESENTATIVE ON (B)(6) 2019 AND OBTAINED ADDITIONAL INFORMATION: "MEDICATION INFUSED: SALINE/INSULIN DATE EVENT NOTICED: WE PULLED THE PUMP OUT OF SERVICE IN DECEMBER BECAUSE IT WOULD GIVE A SOFTWARE ERROR MESSAGE. WE TRIED TO USE IT AGAIN A FEW WEEKS AGO AND IT HAD ALL THE OTHER PROBLEMS. PATIENT INJURY: IT WAS BEING USED ON A PATIENT. WE SWITCHED TO A DIFFERENT PUMP AND WERE ABLE TO GET HER BLOOD SUGAR NUMBERS BACK DOWN TO NORMAL. (NO) DEVICE OPERATOR: OUR MEDICAL TECHNICIAN WAS OPERATING THE PUMP" . NO OTHER PATIENT INFORMATION WAS PROVIDED TO INFUTRONIX.

  Patient problems: Hyperglycemia

  MAUDE report 8596084 ↗
• MalfunctionOct 18, 2018Insufficient Flow or Under Infusion; Infusion or Flow Problem; Power Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem; Power Problem

  THIS IS THE FOLLOW UP REPORT FOR THE INITIALLY SUBMITTED MDR (3011581906-2018-00022).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7977995 ↗
• MalfunctionDec 13, 2017Leak/Splash; Insufficient Flow or Under Infusion; Device Operates Differently Than Expected; Infusion or Flow Problem; Leak/Splash; Insufficient Flow or Under Infusion; Device Operates Differently Than Expected; Infusion or Flow Problem

  THE USER REPORTED AN INFUSION FLOW RATE ISSUE AND A LEAKING ISSUE WITH THE DEVICE. "I WANTED TO LET YOU KNOW THAT WE TRIED A NEW SETTING WITH THE NIMBUS PUMP ON FRIDAY FOR A PATIENT WHO HAD AN OPEN VENTRAL HERNIA REPAIR. IT WAS FOR BILATERAL ESP CATHETERS. WE WERE ABLE TO PROGRAM THE SETTINGS OF 3 ML/HR WITH A 15 ML BOLUS EVERY 3 HOURS. THIS WORKED GREAT UNTIL MONDAY MORNING. THE ALARMS FOR THE RIGHT PUMP SAID E09 FIRST AND THEN E08. THE RIGHT PUMP ALSO SAID THAT THE VOLUME LEFT TO INFUSE WAS 0 ML WHILE THE LEFT PUMP STILL SAID THERE WAS OVER 100 MLS LEFT. WE USED 1000 ML BAG AND BOTH PUMPS WERE SET TO HAVE TOTAL OF 500 ML EACH. WHEN LOOKING AT THE BAG ON MONDAY MORNING, IT APPEARED TO HAVE AT LEAST 200 ML LEFT. WE REPROGRAMMED THEM TO HAVE ANOTHER 100 ML EACH. ANOTHER PROBLEM WE SAW WAS THAT THERE WAS A LEAK SOMEWHERE BECAUSE THE INSIDE OF THE BLACK BAG WAS WET. THE NURSES IDENTIFIED THAT IT WAS THE TUBING FROM THE LEFT PUMP. NONE OF THIS WE CAN EXPLAIN. THE CATHETERS WERE PULLED TODAY AND UPON REVIEWING THE PUMPS, THE TOTAL INFUSED FOR THE RIGHT WAS 575 ML AND FOR THE LEFT WAS 576 ML. VOLUME REMAINING TO BE INFUSED WAS 0 ML EACH. THE FLOOR NURSES WERE FRUSTRATED BECAUSE DURING TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7113507 ↗
• MalfunctionDec 13, 2017Insufficient Flow or Under Infusion; Device Operates Differently Than Expected; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Device Operates Differently Than Expected; Infusion or Flow Problem

  THE USER REPORTED AN INFUSION FLOW RATE ISSUE WITH THE DEVICE. "I WANTED TO LET YOU KNOW THAT WE TRIED A NEW SETTING WITH THE NIMBUS PUMP ON FRIDAY FOR A PATIENT WHO HAD AN OPEN VENTRAL HERNIA REPAIR. IT WAS FOR BILATERAL ESP CATHETERS. WE WERE ABLE TO PROGRAM THE SETTINGS OF 3ML/HR WITH A 15ML BOLUS EVERY 3 HOURS. THIS WORKED GREAT UNTIL MONDAY MORNING. THE ALARMS FOR THE RIGHT PUMP SAID E09 FIRST AND THEN E08. THE RIGHT PUMP ALSO SAID THAT THE VOLUME LEFT TO INFUSE WAS 0ML WHILE THE LEFT PUMP STILL SAID THERE WAS OVER 100MLS LEFT. WE USED 1000ML BAG AND BOTH PUMPS WERE SET TO HAVE TOTAL OF 500ML EACH. WHEN LOOKING AT THE BAG ON MONDAY MORNING, IT APPEARED TO HAVE AT LEAST 200ML LEFT. WE REPROGRAMMED THEM TO HAVE ANOTHER 100ML EACH. THE CATHETERS WERE PULLED TODAY AND UPON REVIEWING THE PUMPS, THE TOTAL INFUSED FOR THE RIGHT WAS 575ML AND FOR THE LEFT WAS 576ML. VOLUME REMAINING TO BE INFUSED WAS 0ML EACH. THE FLOOR NURSES WERE FRUSTRATED BECAUSE DURING THE NIGHT, THE PUMP WAS ALARMING SAYING IT WAS EMPTY WHEN CLEARLY IT WASN'T. SO FROM OUR EXPERIENCE, WE CAN'T REALLY CONFIRM THAT THERE WAS A LEAK FROM THE TUBING. ALSO, WE WILL BE CHECKING WITH OUR PHARMACY TO SEE HOW MUCH THEY AR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7113502 ↗