Nimbus HS-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00817170020048), received between Jun 11, 2020 and Jun 6, 2024 — classified as 100 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (53 reports).

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

1 other recall cover devices cleared under the same FDA submission (K140783); they may or may not involve this specific model.

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 100 reports, 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 ↗
• 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, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "THE POUCH WAS LEAKING AND WET". PATIENT OBSERVED IT WAS "DRIPPING FROM THE TUBING CASSETTE OF THE MACHINE". PATIENT WAS INSTRUCTED TO PAUSE THE THERAPY, CLAMP THE TUBING, AND POWER OFF THE PUMP. PATIENT HAS HAD SURGERY ON THEIR RIBS. DEVICE OPERATOR WAS A PATIENT. MEDICATION BEING INFUSED IS UNKNOWN. NO PATIENT INJURY WAS REPORTED. 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 15539919 ↗
• MalfunctionOct 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF A PATIENT: "THE TUBING CONNECTED TO THE PUMP WAS LEAKING BUT WAS UNABLE TO PINPOINT OR DETERMINE THE EXACT LOCATION OR CAUSE OF THE LEAK." EVENT OCCURRED DURING INFUSION. DEVICE OPERATOR WAS A PATIENT. MEDICATION BEING 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 15539835 ↗
• MalfunctionSep 29, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF A PATIENT: "THE PATIENT HAD PULLED THE TUBING OUT OF THE CASSETTE ON THE DISTAL END WHILE RECEIVING THERAPY AT HOME." DEVICE OPERATOR WAS A PATIENT. 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 15504082 ↗
• MalfunctionSep 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A DISTRIBUTOR OF INFUTRONIX RECEIVED A COMPLAINT FROM A PATIENT: "THE PUMP TUBING APPEARED TO BE LEAKING IN TWO PLACES THE FILTER AND THE LOCK CONNECTION SITE." MEDICATION INFUSED WAS UNKNOWN. DEVICE OPERATOR WAS A PATIENT. 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 15503698 ↗
• MalfunctionSep 28, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF A USER FACILITY REPRESENTATIVE "CLEAR TUBING FEEDING INTO THE CASSETTE BECAME DISCONNECTED FROM THE CASSETTE ITSELF REQUIRING A COMPLETE REPLACEMENT OF THE TUBING." THE MEDICATION INFUSED WAS UNKNOWN. DEVICE OPERATOR 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 15496814 ↗
• MalfunctionSep 27, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF A USER FACILITY REPRESENTATIVE "CLEAR TUBING FEEDING INTO THE CASSETTE BECAME DISCONNECTED FROM THE CASSETTE ITSELF REQUIRING A COMPLETE REPLACEMENT OF THE TUBING." THE MEDICATION INFUSED WAS UNKNOWN. DEVICE OPERATOR 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 15491237 ↗
• MalfunctionSep 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER "I REVERIFIED THE LOCATION OF THE LEAK AND HE DESCRIBED IT AGAIN WITH GREAT CERTAINTY WHERE IT WAS COMING FROM AND IT WAS NEAR THE FILTER ON THE TUBING SIDE OF THE CONNECTION TO THE CATHETER." MEDICATION INFUSED WAS UNKNOWN. DEVICE OPERATOR WAS A PATIENT. 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 15490820 ↗
• MalfunctionSep 16, 2022Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow

  ON 08/22/2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "THEY HAD A DOWNSTREAM OCCLUSION PRIOR TO CALLING AND HAD RESTARTED THE PUMP TO TRY OVERCOMING THE OCCLUSION. THEY CALLED A SECOND TIME SHORTLY AFTERWARD REPORTING LEAKING AT THE AIR FILTER ON THE DISTAL END TOWARD THE PATIENT WILL RECEIVING 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 (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15440852 ↗
• MalfunctionSep 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "THE PUMP WAS LEAKING ALL OVER AND SEEMS TO BE AT THE TUBING THAT GOES TO THE MEDICATION BAG AND BECAME BROKEN AT THE CASSETTE WHILE RECEIVING THERAPY AT HOME. HE HAD ALREADY DISCUSSED THIS WITH THE DOCTOR AND THE DOCTOR HAD ADVISED SINCE HE IS IN DAY 4 OR SO OF THE PUMP USE TO GO AHEAD AND TAKE THE CATHETER OUT AND DISCONTINUE THE USE OF THE PUMP" 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) LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396426 ↗
• MalfunctionSep 7, 2022Break; Break

  ON 08/08/2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "THE TUBE CAME OUT ENTIRELY FROM THE DISTAL END OF THE CASSETTE, WHICH CAUSED LEAKING WHILE THE PATIENT WAS RECEIVING 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 (B)(4) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370179 ↗
• MalfunctionAug 23, 2022Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  ON (B)(6) 2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "THE PUMP TUBING HAD A LOOSE CONNECTION WITH THE CATHETER CONNECTOR WHICH CAUSE LEAKING WHILE RECEIVING THERAPY IN HIS 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 (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15279417 ↗
• MalfunctionAug 19, 2022Break; Break

  ON (B)(6) 2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "HE SAID THAT HE HAS 2 PUMPS, BOTH FELL OFF HIS KNEE SCOOTER HE WAS USING TO GET AROUND AND THE 2 TUBING LINES BROKE. THE PATIENT REPORTED THAT HE WAS ABLE TO PULL THE TUBING OUT AND PUT THE TUBING BACK IN THE PUMP. PATIENT SPOKE TO THE DOCTOR WHO INSTRUCTED TO SHUT DOWN AND REMOVE THE PUMPS" 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 15262476 ↗
• MalfunctionAug 16, 2022Break; Break

  ON (B)(6)2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "THE TUBING WAS PULLED OUT OF THE PUMP AT THE DISTAL END OF THE CASSETTE WHILE RECEIVING THEIR THERAPY AFTER THE PATIENT ACCIDENTALLY FORGOT ABOUT THE PUMP AND GOT UP FROM THE RECLINING CHAIR TO WALK AWAY." 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 15236512 ↗
• MalfunctionAug 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER "THERE WAS LEAKING COMING FROM THE TUBING ON THE PROXIMAL ENTRY SIDE INTO THE PUMP. THIS OCCURRED WHILE THE PATIENT WAS RECEIVING 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 (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15210057 ↗
• MalfunctionJul 27, 2022Break; Break

  ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "THE ADMIN SET TUBING COMPLETELY CAME OUT FROM THE DISTAL END OF THE CASSETTE." THE DISCONNECT OCCURRED DURING INFUSION. 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 15112566 ↗
• MalfunctionJul 12, 2022Break; Break

  ON (B)(6) 2022, A DISTRIBUTOR REPORTED A COMPLAINT TO INFUTRONIX ON BEHALF OF AN END USER: "THE CASSETTE WAS DAMAGE .WHITE SCRATCHED OFF PIECES AT THE CASSETTE HOOKS INDICATES IMPROPER LOADING ON THE CASSETTE." "THE ISSUE DID OCCUR DURING INFUSION BECAUSE THE PATIENT EXPERIENCED A CASSETTE LOADING ERROR BEEPING DURING THERAPY AND BROUGHT ATTENTION TO THE ISSUE." 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 14989056 ↗
• MalfunctionJun 30, 2022Break; Break

  ON (B)(6) 2022, A DISTRIBUTOR REPORTED A COMPLAINT TO INFUTRONIX ON BEHALF OF AN END USER: "THE TUBING HAS DETACHED FROM THE PUMP AT THE DISTAL END OF THE PUMP CASSETTE WHILE RECEIVING THEIR 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 14875395 ↗
• MalfunctionJun 30, 2022Break; Break

  ON 06/07/2022, A DISTRIBUTOR REPORTED A COMPLAINT TO INFUTRONIX ON BEHALF OF AN END USER: "THE TUBING EXITING THE PUMP (DISTAL END) SOMEHOW BECAME UNATTACHED WHILE RECEIVING THEIR 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 14875328 ↗
• MalfunctionJun 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "LEAKING FROM THE CONNECTION OF THE PUMP AND THE CATHETER CONNECTOR. THE CONNECTION BETWEEN THE TWO WAS LOOSE." 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 (B)(4) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14847677 ↗
• MalfunctionJun 28, 2022Break; Break

  ON 06/01/2022, A DISTRIBUTOR REPORTED A COMPLAINT TO INFUTRONIX ON BEHALF OF AN END USER. "THE IV SET CASSETTE ACCIDENTALLY POPPED OFF. THE SILVER HOOKS WERE NOT GETTING DEEP ENOUGH INTO THE NOTCHED-OUT AREA TO LOCK THEM IN PLACE. SOME EXTRA PLASTIC ON THE CATCH OF THE NOTCHED-OUT AREA WAS PREVENTING THE HOOKS FROM GOING IN AND CONNECTING. THE CASSETTE SUSTAINED DAMAGE WHERE THE HOOKS CONNECT AND THE EXTRA PLASTIC PIECES PREVENTING THE HOOKS FROM CONNECTING SHOWS THE CASSETTE WAS IMPROPERLY LOADED ONTO THE PUMP IN THE FIRST PLACE. " DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS UNKNOWN. A PATIENT WAS INVOLVED BUT NOT HARMED. THE EVENT TOOK PLACE DURING AN INFUSION. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14846790 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140783. One submission often covers many models, so check the product and lot details in each record.

• Z-1285-2024 · Feb 21, 2024 · Open, Classified
  Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components