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

Model Number	NIMBUS II PLUS
Medical Device Problem Codes	Failure to Infuse (2340); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint evaluation was completed on 5/28/2024: the pump was tested with the 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.An abrupt power off can be seen below on event line 19 by the "log_event_on" code without an "log_event off" code before it: event 19: log event_on time: 165:165:165 software version: 213 reasons: log on cause onoff eventbytes: 00 ff ff 00 d5 ff 2b fd.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 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.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.Functional testing did confirm the reported condition but was unable to be duplicated.Reported issue found, device does not meet specification.A capa has been opened in order to fully investigate and address the root causes of the reported event.The mdr reportability of this complaint was being upgraded to "yes" on may 17, 2024, as the abrupt power off reported in the complaint is determined to be reportable according to the updated mdr decision tree guide.
Event or Problem Description
It was reported that patient's pump power itself off.No patient harm was reported.

• Brand Name: NIMBUS II AMBULATORY INFUSION SYSTEM
• Common Device Name: AMBULATORY INFUSION PUMP
• Manufacturer (Section D): INFUTRONIX, LLC; 177 pine st; natick MA 01760
• Manufacturer (Section G): INFUTRONIX, LLC; 177 pine st; natick MA 01760
• Manufacturer Contact: frederick lee ; 177 pine st; natick, MA 01760 ; 5086502008
• MDR Report Key: 19536584
• Report Number: 3011581906-2024-00584
• Device Sequence Number: 6171815
• Product Code: FRN
• UDI-Device Identifier: 00817170020161
• UDI-Public: 00817170020161
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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: Health Professional
• Device Model Number: NIMBUS II PLUS
• Device Lot Number: 210325960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1285-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown