NimbusRecalls & reported problems across all models

We found 6 models of Nimbus by Infutronix LLC in the FDA's device registry (GUDID). Together they are named in 225 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2017 and Jun 6, 2024 — classified as 225 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (143 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Nimbus recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 5 of these models · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

Most reported Nimbus problems

Nimbus models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Nimbus HS-002

  Set, Administration, Intravascular
  1 recall100 reports
• Nimbus HS-004

  Set, Administration, Intravascular
  1 recall95 reports
• Nimbus HS-001

  Set, Administration, Intravascular
  1 recall20 reports
• Nimbus HS-003

  Set, Administration, Intravascular
  1 recall6 reports
• Nimbus

  Pump, Infusion, Pca
  1 recall4 reports
• Nimbus Nimbus II EMS

  Pump, Infusion, Pca
  1 recall0 reports

Recent Nimbus adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2024Contamination; Contamination

  05/08/2024, INFUTRONIX MEDICAL RECEIVED A REPORT FROM THE PATIENT THAT THE TUBING HAD SEPARATED FROM THE CATHETER. THE PATIENT STATED THAT PER THE DOCTOR'S INSTRUCTIONS THEY WERE DIRECTED TO REMOVE THE CATHETER. UPON REMOVING IT, THE PATIENTT STATED THAT THE REMAINING THERAPY/MEDICATION WAS LOST. NO PATIENT INJURY/HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19479562 ↗
• MalfunctionMay 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED "INFUSION LEAKING AT THE FILTER". REPORTEDLY THE PATIENT STATED THEY "HAD A PAPER TOWEL AROUND IT WHEN THEY WENT TO BED LAST NIGHT AND WOKE UP AT 2AM WITH A FEW SPOTS ON THE PAPER TOWEL. PATIENT PUT A NEW PAPER TOWEL AROUND IT AND COVERED WITH SARAN WRAP AND CAME TO THE CLINIC FIRST THING THIS MORNING". THE TUBING WAS NOT BROKEN, SEPARATED, CRACKED, OR DETACHED. THERE WAS NO VISIBLE HARM TO THE FILTER. "PATIENT CAME BACK TO THE CLINIC TO HAVE THE TUBING CHANGED, WHEN THEY RETURNED ON FRIDAY PATIENT STATED THERE WAS AIR IN THE TUBING UNTIL IT REACHED THE FILTER THEN WOULD BE JUST MEDICATION PAST THE FILTER. PATIENT STATED THEY HAD TO OPEN UP THE FANNY PACK THE BAG WAS IN AND SIT IT NEXT TO THEM TO NOT HAVE IT ALARM." MEDICATION BEING INFUSED WAS EPOCH - DOXORUBICIN, ETOPOSIDE, VINCRISTINE IN A 1000ML BAG TO INFUSE OVER 48 HOURS. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004225 ↗
• MalfunctionApr 25, 2023Break; Contamination; Fluid/Blood Leak; Break; Contamination; Fluid/Blood Leak

  PATIENT REPORTED "DOG SCRATCHED A HOLE IN THE TUBING AND IT WAS LEAKING". THE PUMP WAS POWERED DOWN, AND THE LINE WAS CLAMPED. THE PATIENT WAS BAGGING THE PUMP AND HAD A NO SPILL KIT. HEALTHCARE PROFESSIONAL REPORTED THERE WERE NO OTHER DEVICES INVOLVED IN THIS EVENT. LEAK OCCURED 45 HOURS INTO INFUSION. "INFUSION WAS ALMOST COMPLETE - NO NEED TO RESUME". PATIENT TOLD NURSE NOTHING LEAKED AT HOME. MEDICATION BEING INFUSED WAS 5FU. HEALTHCARE PROFESSIONAL CONFIRMED THERE WAS NO MEDICAL EVENT, AND PATIENT DID NOT REQUIRE ANY TREATMENT OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809236 ↗
• MalfunctionFeb 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A DISTRIBUTOR OF INFUTRONIX RECEIVED A COMPLAINT FROM A PHARMACIST, REPORTEDLY THE PATIENT WENT TO THE HOSPITAL FOR A SCHEDULED BLOOD TRANSFUSION AND PASSED AWAY "SHORTLY AFTER ARRIVING TO THE HOSPITAL". "THE HOSPITAL PUT EVERYTHING IN A BAG ALONG WITH THE DRUG/FLUID BAG." THE "TUBING WAS NOT CLAMPED WHEN IT WAS DISCONNECTED AND THE MEDICATION, BLINCYTO, LEAKED OUT". THE BAG AND TUBING WERE RETAINED FOR A SHORT TIME AFTER THE PRODUCT WAS RECEIVED FROM THE HOSPITAL. DURING THAT TIME, THE REPORTER INDICATED THEY "DID HOOK IT UP TO ANOTHER PUMP AND DID TEST IT WITH A NURSING SUPERVISOR." DURING THE TESTING THEY "COULD NOT FIND ANY LEAKS IN THE TUBING OR THE BAG. IT WAS VERY HARD TO REPLICATE THE OCCLUSION ERROR THE WAY A PICC LINE WOULD." THE TESTERS "CLAMPED IT OFF, TRIED TO SLIGHTLY OCCLUDE IT BUT IT WOULD NEVER LEAK ANYWHERE." THE REPORTER LATER CLARIFIED: "THE PICC LINE DISCUSSION OCCURRED WITH AN EMPLOYEE AT ZYNO SOLUTIONS. PICC LINES CAN SOMETIMES CAUSE OCCLUSIONS. IT IS A SIDE NOTE THAT THE PATIENT HAD A PICC LINE SINCE WE DID NOT HAVE ALL THE INFORMATION ON WHERE AND HOW THE PUMP WAS DAMAGED. UPON FINDING MORE INFORMATION OUT THE PICC LINE PRESSURE DID NOT CAUSE THE LEAK." MED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16400601 ↗
• MalfunctionDec 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A DISTRIBUTOR OF INFUTRONIX RECEIVED A COMPLAINT FROM A HEALTHCARE PROFESSIONAL, WHO REPORTED ADMINISTRATION SET LEAKED FROM THE FILTER. DEVICE OPERATOR WAS A HEALTHCARE PROFESSIONAL. MEDICATION BEING INFUSED WAS 5FU. NO PATIENT INJURY REPORTED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16072554 ↗
• MalfunctionDec 16, 2022Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  INFUTRONIX RECEIVED A COMPLAINT FROM A HEALTHCARE PROFESSIONAL, WHO REPORTED "THE TUBING ENDED UP MALFUNCTIONING, LEAKING THE CHEMOTHERAPY EVERYWHERE. WE INSPECTED THE TUBING AND FOUND THAT IT WAS DISCONNECTED INSIDE THE CARTRIDGE THAT CONNECTS TO THE PUMP." OPERATOR OF DEVICE WAS A NURSE. MEDICATION BEING INFUSED IS UNKNOWN. NO PATIENT INJURY REPORTED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15995327 ↗
• MalfunctionNov 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  INFUTRONIX RECEIVED A COMPLAINT FROM A USER FACILITY REPRESENTATIVE, WHO REPORTED "THE TUBING WAS LEAKING FROM THE FILTER". THE CHEMO LEAKED ALL OVER THE PATIENT'S CLOTHES AND CAR SEAT.. DEVICE OPERATOR WAS A PATIENT. MEDICATION BEING INFUSED WAS 5FU. NO PATIENT INJURY REPORTED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15798391 ↗
• MalfunctionOct 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT FROM A HEALTHCARE PROFESSIONAL: THE ADMIN SET TUBING BROKE WHERE IT CAME APART AT THE CASSETTE. "THE TUBING HAS COME OUT FROM THE CONNECTOR". PATIENT RETURNED TO THE FACILITY TO GET FURTHER ATTENTION AND TO RETURN THE DEFECTIVE TUBING. DEVICE OPERATOR WAS THE PATIENT. MEDICATION BEING INFUSED WAS UNKNOWN. NO PATIENT INJURY REPORTED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15575154 ↗
• MalfunctionOct 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF A PATIENT: "A PUMP LEAK" AROUND A BLUE VALVE. PATIENT COULD NOT SPECIFY THE EXACT SOURCE OF THE LEAK. PATIENT WAS INSTRUCTED TO TURN THE PUMP OFF AND CLAMP THE LINE. DEVICE OPERATOR WAS THE PATIENT. MEDICATION BEING INFUSED WAS 5FU. NO PATIENT INJURY REPORTED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15574633 ↗
• MalfunctionOct 11, 2022Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  A DISTRIBUTOR OF INFUTRONIX RECEIVED A COMPLAINT FROM A HEALTHCARE PROFESSIONAL (HCP) REPORTING "THE ADMIN SET TUBING FELL APART". TUBING DISCONNECTED FROM THE CASSETTE AT THE PROXIMAL END, AND LEAKED. PATIENT RETURNED TO THE FACILITY TO GET FURTHER ATTENTION AND TO RETURN THE DEFECTIVE TUBING. DEVICE OPERATOR WAS THE PATIENT. MEDICATION BEING INFUSED WAS UNKNOWN. NO PATIENT INJURY REPORTED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15574433 ↗
• MalfunctionOct 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  INFUTRONIX RECEIVED A COMPLAINT FROM A PATIENT: "THE TUBING CAME OUT THE PUMP ON THE SIDE THE MEDICATION ENTERS THE PUMP" (PROXIMAL ENTRY POINT). DEVICE OPERATOR WAS A PATIENT. MEDICATION BEING INFUSED WAS UNKNOWN. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY REPORTED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15570452 ↗
• MalfunctionOct 6, 2022Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF A PATIENT: "THE PATIENT WAS GETTING UP WHEN THE TUBING HOOKED ON SOMETHING AS THE TUBING BROKE OFF AT THE IV BAG AND BROKE THE PLASTIC CONNECTOR WHILE RECEIVING THERAPY." EVENT OCCURED DURIG INFUSION. MEDICATION BEING INFUSED WAS UNKNOWN. NO PATIENT INJURY. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (B)(6) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15554053 ↗
• MalfunctionOct 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR OF INFUTRONIX RECEIVED A COMPLAINT FROM USER FACILITY REPRESENTATIVE "THE CASSETTE TUBING ON PUMP BECAME DISCONNECTED SEVERAL TIMES DURING THE INFUSION." DEVICE OPERATOR WAS UNKNOWN. MEDICATION INFUSED WAS UNKNOWN. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (B)(6) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540267 ↗
• MalfunctionOct 4, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A DISTRIBUTOR OF INFUTRONIX RECEIVED A COMPLAINT FROM A PATIET, WHO REPORTED STANDING UP FROM A CHAIR AND PULLING THE TUBING OUT OF THE IV BAG. THE PATIENT TRIED TO PUT IT BACK IN BUT THEN BROKE THE PLASTIC PART. EVENT OCCURED DURIG INFUSION. MEDICATION BEING INFUSED WAS UNKNOWN. NO PATIENT INJURY. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540263 ↗
• MalfunctionOct 4, 2022Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF A PATIENT, STATING THAT DURING INFUSION, THE PUMP WAS ACCIDENTALLY KNOCKED TO THE FLOOR. IN THE PROCESS, THE TUBING PULLED/CAME OUT FROM THE WHITE CONNECTOR AT THE DISTAL END OF THE CASSETTE FACING TOWARD THE PATIENT'S CATHETER CONNECTION. MEDICATION BEING INFUSED WAS UNKNOWN. NO PATIENT INJURY. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540186 ↗