MAUDE Adverse Event Report: INFUTRONIX, LLC NIMBUS II PLUS AMBULATORY INFUSION PUMP

Model Number	NIMBUS II PLUS
Medical Device Problem Codes	Power Problem (3010); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted on 06/26/2024 as when the complaint was first processed the code "2pow3: power issue" was not a reportable event on 06/06/2023.Per intuvie complaint protocol this is now a reportable event.Due to intuvie complaint closing process the complaint was closed.The complaint record is now been reopened due to the device was returned for evaluation on 06/04/2024.There are no other complaints on this device.The pump was tested with the following testing protocol for battery and power complaints.It is noted that the pump was received without a battery in the pump, as the one used by the end user was not returned.A new battery was put into the pump in order to complete the test.A 100 ml infusion was ran on the pump using the end user's parameters of a 46 hour infusion.The infusion ran for 100 ml at a rate of 2.2 ml per hour.The infusion was successfully completed and the pump did not power off abruptly before finishing.The infusion was ran using an hs-008 iv cassette with lot # 2301005 and expiration date 02/01/2026.Functional testing did confirm the reported condition, device does not meet specification.This complaint has been reviewed, evaluated, and determined to be a part of capa.Reference complaint # (b)(4).
Event or Problem Description
On 06/06/2024, infutronix received a report from the patient stating they woke to a blank screen.Patient stated she went to the clinic and they reprogrammed her pump and sent her on her way (no battery was replaced that she is aware of).Patient is calling because the pump died again.Tech support attempted powering it back up only to find new infusion only.The pump has lost all its infusion parameters.Patient was instructed to power the unit back off and clamped the line.Tech supported instructed the patient to go to her infusion center to get the pump replaced.No patient injury/harm reported.

• Brand Name: NIMBUS II PLUS AMBULATORY INFUSION PUMP
• Common Device Name: AMBULATORY INFUSION PUMP
• Manufacturer (Section D): INFUTRONIX, LLC; 177 pine street; natick MA 01760
• Manufacturer (Section G): INFUTRONIX LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: frederick lee ; 177 pine street; natick, MA 01760 ; 5086502007
• MDR Report Key: 19619637
• Report Number: 3011581906-2024-00602
• Device Sequence Number: 12501358
• Product Code: FRN
• UDI-Device Identifier: 00817170020161
• UDI-Public: 00817170020161
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: NIMBUS II PLUS
• Device Catalogue Number: NIMBUS II PLUS
• Device Lot Number: 2202072880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female