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	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/04/2024, infutronix received a report from the customer reporting that after much troubleshooting the pump continued to turn off and was constantly beeping can we send her a new pump please.No patient injury/harm reported.
Additional Manufacturer Narrative
This report is being submitted on 06/25/2024 as an initial report due to the pump was received for analysis on 05/21/2024.The analysis was completed on 05/28/2024 which confirmed it was a reportable event.There are no other complaints on this device.The pump was tested with the following testing protocol for battery and power complaints.The pump's event log was pulled as part of the evaluation and upon review it was noted that there were several abrupt power offs found in the log, as reported by the end user.Abrupt power offs can be seen on event lines 522-526 by the "log_event_on" code without an "log_event_off" code before it: seeing the code "log_event_on" code without an "log_event_off" code before it points to the abrupt power off as it means that the pump had to be powered on without being powered off prior, meaning that it turned off on its own.A 100 ml infusion was unable to be ran on a pump due to a limitation with the customer's library configuration.The pump was set to run a 20 ml infusion at a rate of 0.8 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 # 2304023 and expiration date 03/17/2026.Upon further evaluation there were no loose connections or components inside of the device, which could have contributed to the reported malfunction and the instances found in the event log.It was also noted that the pump's label with all of the model information was completely erased, with the only way to verify the pump's information is by physically turning it on to see all information as it powers up.Functional testing did confirm the reported condition but was unable to be duplicated.Reported issue found, device does not meet specification.This complaint has been reviewed, evaluated, and determined to be a part of capa.Reference complaint # (b)(4).

• 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: 19610234
• Report Number: 3011581906-2024-00608
• Device Sequence Number: 20423007
• Product Code: FRN
• UDI-Device Identifier: 00817170020161
• UDI-Public: 00817170020161
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/25/2024

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: 05/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 06/25/2024
• 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 Sex: Unknown