Nimbus HS-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 00817170020031), received between Feb 21, 2018 and May 25, 2023 — classified as 95 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (78 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-1286-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 95 reports, in the reporter's own words as published by the FDA.

• 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 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 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 ↗
• MalfunctionSep 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  INFUTRONIX RECEIVED A COMPLAINT FROM A USER FACILITY REPRESENTATIVE: "AN ADMINISTRATION SET MODEL HS-004 LOT 2106005 HAD A LEAK FROM THE FILTER OF THE TUBING. IT TOOK PLACE DURING A PATIENTS INFUSION. THERE WERE NO VISIBLE HOLES OR CRACKS IN THE TUBING, OR NEAR THE FILTER. NO BLOOD LOSS OR BLEED BACK WAS OBSERVED. THE PATIENT DID FOLLOW THE CLEAN UP PROCEDURE." MEDICATION INFUSED WAS EPOCH. DEVICE OPERATOR WAS A PATIENT. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491422 ↗
• MalfunctionJul 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "HE CALLED WITH THE MEDICATION LEAKING. THEY INDICATED THAT THIS WAS THE SECOND LEAK IN TWO DAYS." THE LEAK OCCURRED DURING AN INFUSION. DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15113562 ↗
• MalfunctionJul 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON 06/29/2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "PUMP LEAKING. PER PATIENT REPORT, LEAK NEAR SQUARE INDICATING NEAR FILTER." THE LEAK OCCURRED DURING AN INFUSION. DEVICE OPERATOR WAS A NURSE. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15113445 ↗
• MalfunctionJul 18, 2022Leak/Splash; Leak/Splash

  ON (B)(6) 2022 , INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "WE HAD A PATIENT COME BACK FOR DISCONNECT AND THEY HAD A PROBLEM WITH THE TUBING LEAKING FROM AROUND THE FILTER." DEVICE OPERATOR WAS A NURSE. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15046133 ↗
• MalfunctionMar 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6)2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "3 SETS ALL FROM DIFFERENT LOCATIONS, WERE LEAKING FROM A FILTER FROM WHAT EVERYONE WAS DESCRIBING TO ME." DEVICE OPERATOR WAS A ONCOLOGY CLINICAL DIRECTOR. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(6) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13905633 ↗
• MalfunctionMar 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "3 SETS ALL FROM DIFFERENT LOCATIONS, WERE LEAKING FROM A FILTER FROM WHAT EVERYONE WAS DESCRIBING TO ME." DEVICE OPERATOR WAS A ONCOLOGY CLINICAL DIRECTOR. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13893437 ↗
• MalfunctionMar 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "3 SETS ALL FROM DIFFERENT LOCATIONS, WERE LEAKING FROM A FILTER FROM WHAT EVERYONE WAS DESCRIBING TO ME." DEVICE OPERATOR WAS A ONCOLOGY CLINICAL DIRECTOR. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13893194 ↗
• MalfunctionMar 10, 2022Loss of or Failure to Bond; Break; Loss of or Failure to Bond; Break

  ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-004, LOT 2106005 SET BROKE AT THE CONNECTION OF THE CASSETTE." DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(6) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13722877 ↗
• MalfunctionMar 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: A MEDICATION LEAK AT THE FILTER. THE END USER SAID HE COULD SEE WHITE CRYSTALS AROUND THE FILTER. DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13673685 ↗
• MalfunctionMar 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "ADMINISTRATION SET MODEL HS-004, LOT 2106005, SET WAS LEAKING FROM THE TUBING." IT IS UNKNOWN WHERE THE LEAK IS COMING FROM. "THIS HAPPENED TO A PATIENT, WHILE AT HOME RECEIVING A TREATMENT." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13673563 ↗
• MalfunctionMar 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-004, LOT 2106005, SET WAS LEAKING FROM THE SIDES OF THE FILTER FROM A TREATMENT THAT TOOK PLACE TODAY. THIS HAPPENED TO A PATIENT, WHILE AT HOME RECEIVING A TREATMENT." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13673499 ↗
• MalfunctionMar 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON 02/08/2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-004, LOT 2106005, SET WAS LEAKING FROM THE SIDES OF THE FILTER. THE PATIENT HAD NOTICED HER SHIRT HAD GOTTEN WET." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13652109 ↗
• MalfunctionMar 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON 02/08/2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-004, LOT 2106005 SET WAS LEAKING FROM THE SIDES OF THE FILTER. THE PATIENT HAD NOTICED HER SHIRT HAD GOTTEN WET AGAIN." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13643372 ↗
• MalfunctionFeb 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "SHE WENT TO CHANGE HER BLOUSE AND NOTICED THERE WAS A WET SPOT. SHE SAID SHE TOOK THE MEDICATION OUT OF THE BAG AND NOTICED HER DRESSING WAS WET." INFUTRONIX FOLLOWED UP WITH THE USER FACILITY, THE REGISTERED NURSE (B)(6) FROM (B)(6) CANCER SPECIALIST CONFIRMED THE TUBING WAS LEAKING FROM THE EDGE OF THE FILTER DURING THE INFUSION. DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(6) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497674 ↗
• MalfunctionJan 18, 2022Break; Break

  ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-004, LOT 2008003 SET BROKE OFF FROM THE CASSETTE." DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13286130 ↗
• MalfunctionJan 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2021, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "AN ADMINISTRATION SET MODEL HS-004, LOT 2106005 WAS LEAKING AT THE CONNECTION OF THE FILTER." THE EVENT HAPPENED DURING AN INFUSION. DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13232851 ↗
• MalfunctionJan 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2021, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "AN ADMINISTRATION SET MODEL HS-004, LOT 2106005 WAS LEAKING AT THE CONNECTION OF THE FILTER." THE EVENT HAPPENED DURING AN INFUSION. DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13232807 ↗
• MalfunctionJan 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2021, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-004 LOT 2106005 WAS LEAKING AT THE CONNECTION BELOW THE FILTER." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173153 ↗
• MalfunctionJan 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2021, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-004 LOT 2106005 WAS LEAKING AT THE CONNECTION BELOW THE FILTER." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173151 ↗