Nimbus HS-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00817170020017), received between Jun 14, 2019 and Dec 29, 2022 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJul 19, 2022Leak/Splash; Leak/Splash

  ON 06/21/2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AFTER YOU LEFT THIS MORNING, WE HAD A PATIENT COME IN AND IN CONVERSATION HE SAID HE THOUGHT HIS PUMP LEAKED OVER THE NIGHT SOMETIME. HE SHOWED ME HIS TUBING AND I SNAPPED A COUPLE OF PICTURES. FROM WHAT IT LOOKS LIKE, THE CHEMO LEAK HAPPENED AT THE FILTER SITE AND GOT ONTO THE BLUE CLAMP." 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 15052077 ↗
• MalfunctionJul 13, 2022Break; Break

  ON (B)(6) 2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "THE TUBING BROKE OFF AT THE DISTAL END OF THE CASSETTE." THE EVENT OCCURRED DURING INFUSION. DEVICE OPERATOR WAS A NURSE. MEDICATION INFUSED WAS UNKNOWN. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4) LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15000897 ↗
• MalfunctionMay 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON 04/12/2022. A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: LEAKING COMING FROM THE TUBING CONNECTED TO THE PUMP AND THE BLACK POUCH WAS WET. DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS UNKNOWN. 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 14290673 ↗
• MalfunctionMay 5, 2022Break; Break

  ON (B)(6) 2022. A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "THE TUBING CAME OUT THE PROXIMAL ENTRY POINT WHILE RECEIVING THERAPY." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS UNKNOWN. 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 14290644 ↗
• MalfunctionApr 4, 2022Connection Problem; Connection Problem

  ON (B)(6) 2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT FROM AN END USER: "THE CLEAR TUBE ITSELF CAME OUT FROM THE WHITE TUBE CONNECTOR AT THE SIDE OF THE WHITE CASSETTE." THE END USER MENTIONED THIS HAPPENED WHEN THEY WERE ON THE COUCH WHILE RECEIVING HER THERAPY AT HOME. DEVICE OPERATOR WAS A PATIENT. 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 14000191 ↗
• MalfunctionJun 30, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR 3011581906-2021-00045.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12097456 ↗
• MalfunctionJun 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2021, A DISTRIBUTOR OF INFUTRONIX REPORTED AN ISSUE ON BEHALF OF AN END USER: "ADMIN SET TUBING WAS LEAKING AT THE CONNECTION WHERE THE CATHETER CONNECTOR IS." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS UNKNOWN. 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 11926349 ↗
• MalfunctionMay 14, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR 3011581906-2021-00024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11828472 ↗
• MalfunctionJan 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2020, A DISTRIBUTOR OF INFUTRONIX REPORTED AN ISSUE ON BEHALF OF AN END USER: "PATIENT'S DAUGHTER CALLING TO LET US KNOW THERE WAS LEAKING FROM THE TUBING WHERE IT CONNECTS TO THE CASSETTE. THE TUBING WAS "BENT UP AGAINST THE PUMP" AND THE BAG WAS VERY WET." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS UNKNOWN. 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 11159667 ↗
• MalfunctionJan 6, 2021Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  ON 12/10/2020, A DISTRIBUTOR OF INFUTRONIX REPORTED AN ISSUE ON BEHALF OF AN END USER: "THE PATIENT'S TUBING BECAME DISCONNECTED FROM THE YELLOW CONNECTOR." DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION INFUSED WAS UNKNOWN. 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 11124645 ↗
• MalfunctionNov 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ON 10/14/2020, A DISTRIBUTOR OF INFUTRONIX REPORTED THE FOLLOWING ON BEHALF OF AN END USER : "RECEIVED AN EMAIL FROM (B)(6) THAT THERE WAS A LEAKING PAIN PUMP." A PATIENT WAS INVOLVED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA ((B)(4)) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10820404 ↗
• MalfunctionJul 2, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  ON 06/26/2019, A DISTRIBUTOR OF INFUTRONIX REPORTED A LEAKING ISSUE. THE DISTRIBUTOR RECEIVED THE FOLLOWING INFORMATION FROM THE USER FACILITY: "WE ROUNDED ON A PATIENT AND THEY STATED THEIR PUMP WAS LEAKING. THE PATIENT AND NURSE STATED THE FLUID WAS COMING FROM THE ACTUAL PUMP (SO LIKELY THE TUBING CLAMPED IN THE PUMP). THE CATHETER SITE WAS COMPLETELY DRY." NO PATIENT INFORMATION WAS REPORTED TO INFUTRONIX. NO INFORMATION ON THE MEDICATION USED AT THE TIME OF THE EVENT WAS AVAILABLE. NO PATIENT INJURY OR HARM WAS REPORTED FOR THIS EVENT. THE DISTRIBUTOR HAS NOT PROVIDED THE INFORMATION FOR THE INFUSION PUMP USED AT THE TIME OF THE EVENT. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8755321 ↗
• MalfunctionJun 14, 2019Loss of or Failure to Bond; Material Integrity Problem; Loss of or Failure to Bond; Material Integrity Problem

  ON 06/11/2019, A DISTRIBUTOR OF INFUTRONIX REPORTED A TUBING DETACHMENT ISSUE: "PUMP WAS WITH PATIENT IN BED. RN CHECKED THE SHIFT TOTAL FOR CHARTING INFORMATION (PUMP WAS NOT REMOVED FROM BAG). RN NOTICED THE BAG WAS WET AND THEN UNZIPPED IT TO FIND THE IV SET TUBING COMPLETELY DISCONNECTED FROM THE DISTAL END OF THE CASSETTE CONNECTOR." NO PATIENT INFORMATION WAS REPORTED TO INFUTRONIX. NO INFORMATION ON THE MEDICATION USED AT THE TIME OF THE EVENT WAS AVAILABLE. NO PATIENT INJURY OR HARM WAS REPORTED FOR THIS EVENT. ON 06/13/2019, THE DISTRIBUTOR REPORTED THAT THE AFFECTED DEVICE WAS DISCARDED AT THE USER FACILITY. NO INFORMATION ON THE EXPIRATION DATE OR MANUFACTURING DATE OF THE AFFECTED DEVICE WAS AVAILABLE. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA ((B)(4)) MEDICAL CO. LTD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8701078 ↗
• MalfunctionJun 14, 2019Loss of or Failure to Bond; Material Integrity Problem; Loss of or Failure to Bond; Material Integrity Problem

  ON 06/06/2019, A DISTRIBUTOR OF INFUTRONIX REPORTED A TUBING DETACHMENT ISSUE: "IV SET LOT# IS UNKNOWN AND THE SET WILL BE RETURNED FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY. TUBING DID NOT LEAK. THE TUBING BECAME ENTIRELY DETACHED FROM CASSETTE CONNECTOR SITE. I HAVE ATTACHED PHOTOS." NO PATIENT INFORMATION WAS REPORTED TO INFUTRONIX. NO INFORMATION ON THE MEDICATION USED AT THE TIME OF THE EVENT WAS AVAILABLE. ON 06/13/2019, THE DISTRIBUTOR REPORTED THAT THE USER FACILITY HAD DISPOSED THE AFFECTED DEVICE. NO INFORMATION ON THE EXPIRATION DATE OR MANUFACTURING DATE OF THE AFFECTED DEVICE WAS AVAILABLE. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8701072 ↗
• MalfunctionJun 14, 2019Loss of or Failure to Bond; Material Integrity Problem; Loss of or Failure to Bond; Material Integrity Problem

  ON 06/10/2019, A DISTRIBUTOR OF INFUTRONIX REPORTED A TUBING DETACHMENT ISSUE: "IV SET TUBING DETACHED FROM DISTAL END OF CASSETTE CONNECTOR SITE". NO INFORMATION ON THE MEDICATION USED AT THE TIME OF THE EVENT WAS AVAILABLE. NO PATIENT INFORMATION OR INJURY WAS REPORTED TO INFUTRONIX. NO INFORMATION ON THE EXPIRATION DATE OR MANUFACTURING DATE OF THE AFFECTED DEVICE WAS AVAILABLE. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA ((B)(4)) MEDICAL CO. LTD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8701071 ↗
• MalfunctionJun 14, 2019Loss of or Failure to Bond; Material Integrity Problem; Loss of or Failure to Bond; Material Integrity Problem

  ON (B)(6) 2019, A DISTRIBUTOR OF INFUTRONIX REPORTED A TUBING DETACHMENT ISSUE: "PUMP WAS WITH PATIENT IN BED. RN CHECKED THE SHIFT TOTAL FOR CHARTING INFORMATION (PUMP WAS NOT REMOVED FROM BAG). RN NOTICED THE BAG WAS WET AND THEN UNZIPPED IT TO FIND THE IV SET TUBING COMPLETELY DISCONNECTED FROM THE DISTAL END OF THE CASSETTE CONNECTOR." NO PATIENT INFORMATION WAS REPORTED TO INFUTRONIX. NO INFORMATION ON THE MEDICATION USED AT THE TIME OF THE EVENT WAS AVAILABLE. NO PATIENT INJURY OR HARM WAS REPORTED FOR THIS EVENT. ON (B)(6) 2019, THE DISTRIBUTOR REPORTED THAT THE AFFECTED DEVICE WAS DISCARDED AT THE USER FACILITY. NO INFORMATION ON THE EXPIRATION DATE OR MANUFACTURING DATE OF THE AFFECTED DEVICE WAS AVAILABLE. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8701067 ↗