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

Model Number	NIMBUS II PAINPRO
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The historical test records were reviewed in the qos system.All test relevant to the reported issue have passed.All other tests were found to have been completed.Service tests were completed three times on the pump: 01/18/2021, 12/24/2021, and 1/10/2023, with all tests passing.Complaint evaluation was completed on 05/17/2024.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.An abrupt power off can be seen in the event log on event lines 0-3 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 it's own.The mdr reportability of this complaint was being upgraded to "yes", as the condition was determined to be reportable according to the updated mdr decision tree guide.Upon further evaluation there were no loose connections or components inside of the device.Reported issue found, device does not meet specification.A capa had been opened in order to fully investigate and address the root causes of the reported events.[reference: complaint # (b)(4)].
Event or Problem Description
Pump was returned on (b)(6) 2024 and evaluated.The mdr reportability of this complaint was being upgraded to "yes", as the abrupt power off reported by the end user was now determined to be reportable according to the updated mdr decision tree guide.Patient was involved, but not harmed.

• Brand Name: NIMBUS II PAINPRO 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: 19359455
• Report Number: 3011581906-2024-00574
• Device Sequence Number: 20418685
• Product Code: FRN
• UDI-Device Identifier: 00817170020086
• UDI-Public: 00817170020086
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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 PAINPRO
• Device Catalogue Number: NIMBUS II PAINPRO
• Device Lot Number: 170907-1188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2017
• 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