Nimbus HS-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00817170020024), received between May 24, 2019 and Apr 15, 2022 — classified as 6 malfunctions.

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

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "THE HEMATOLOGY CLINIC HAS HAD ANOTHER ISSUE WITH THE TUBING ATTACHED TO A BLINCYTO FOR A NIMBUS PUMP. IT WAS LEAKING AROUND THE FILTER." DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION INFUSED WAS BLINCYTO. 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 14119468 ↗
• MalfunctionMar 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON(B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-003, LOT 2004017 WAS LEAKING FROM A SMALL HOLE IN THE TUBING." 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 13643254 ↗
• MalfunctionMar 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-003, LOT 2004017 WAS LEAKING FROMA A SMALL HOLE IN THE TUBING." 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 13643248 ↗
• MalfunctionJul 17, 2019Component Misassembled; Component Misassembled

  ON 07/05/2019, A DISTRIBUTOR OF INFUTRONIX REPORTED A CASSETTE BACKWARDS ISSUE. THE DISTRIBUTOR RECEIVED AN ADMINISTRATION SET WITH A NOTE AND A PRINTED EMAIL FROM THE USER FACILITY. THE EMAIL STATED THE SET WAS FROM LOT # 1712004. THE NOTE STATED "MANUFACTURER DEFECT. GREEN CLAMP ON WRONG END OF THE CASSETTE." INSULINE AND NORMAL SALINE WERE THE MEDICATIONS BEING INFUSED. NO PATIENT INJURY OR HARM WAS REPORTED FOR THIS EVENT. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8800413 ↗
• MalfunctionMay 24, 2019Leak/Splash; Leak/Splash

  INFUTRONIX RECEIVED AN AIR-IN-LINE ISSUE WITH THE ADMINISTRATION SET ON (B)(6) 2019 FROM A DISTRIBUTOR. ON (B)(4) 2019, A DISTRIBUTOR REPRESENTATIVE RECEIVED INFORMATION FROM A COLLEAGUE WHO REPORTED THE COMPLAINT ON BEHALF OF THE USER FACILITY THAT THE USER FACILITY "HAD SEVERAL ISSUES WITH NIMBUS IV SETS NOT PERFORMING PROPERLY". IT WAS ALSO REPORTED THAT "A SMALL AMOUNT OF AIR WAS PRESENT IN THESE SETS, THE NURSES CAUGHT IT RIGHT AWAY, AND THERE WAS NO HARM TO PATIENTS". THE LOT NUMBER OF THE AFFECTED DEVICE WAS UNKNOWN. NO EVENT DATE WAS PROVIDED TO INFUTRONIX. TWO AFFECTED SETS WOULD BE RETURNED TO THE DISTRIBUTOR FOR EXAMINATION; THEY ARE REPORTED UNDER THIS MDR AND MDR #3011581906-2019-00006.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8642591 ↗
• MalfunctionMay 24, 2019Leak/Splash; Leak/Splash

  INFUTRONIX RECEIVED AN AIR-IN-LINE ISSUE WITH THE ADMINISTRATION SET ON 05/06/2019 FROM A DISTRIBUTOR. ON 04/01/2019, A DISTRIBUTOR REPRESENTATIVE RECEIVED INFORMATION FROM A COLLEAGUE WHO REPORTED THE COMPLAINT ON BEHALF OF THE USER FACILITY THAT THE USER FACILITY "HAD SEVERAL ISSUES WITH NIMBUS IV SETS NOT PERFORMING PROPERLY". IT WAS ALSO REPORTED THAT "A SMALL AMOUNT OF AIR WAS PRESENT IN THESE SETS, THE NURSES CAUGHT IT RIGHT AWAY, AND THERE WAS NO HARM TO PATIENTS". THE LOT NUMBER OF THE AFFECTED DEVICE WAS UNKNOWN. NO EVENT DATE WAS PROVIDED TO INFUTRONIX. TWO AFFECTED SETS WOULD BE RETURNED TO THE DISTRIBUTOR FOR EXAMINATION; THEY ARE REPORTED UNDER THIS MDR AND MDR #3011581906-2019-00007.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8642553 ↗