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	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint evaluation was completed on 6/6/2024: it was also noted during the event log review that the pump was found to undergo an abrupt power off, which can be seen below on event line 365: event 365: log_event_on time: 165:165:165 software_version: 213 reason: 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.Functional testing did confirm the reported condition, 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 pump's records were reviewed, as all previous test records were reviewed and all were found to have passed, with manufacturing final testing being completed on 11/09/2022.
Event or Problem Description
During product evaluation on june 6, 2024, it was determined that device abruptly power itself off.

• 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 ; 5086502800
• MDR Report Key: 19538169
• Report Number: 3011581906-2024-00594
• Device Sequence Number: 12864936
• Product Code: FRN
• UDI-Device Identifier: 00817170020161
• UDI-Public: 00817170020161
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,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: 2208092040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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
• 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