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

Model Number	NIMBUS II FLEX
Medical Device Problem Codes	Device Alarm System (1012); Device Sensing Problem (2917); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, infutronix received a report that a pump had an "unknown issue - unknown issue from customer".The infusion cannot resume without causing delay in treatment.No patient was involved and harmed.Device was returned on 01/24/2024.Detail of the evaluation can be found in section h of this mdr.
Additional Manufacturer Narrative
Dhr was reviewed, and the pump passed all previous tests.There are no previous complaints on this device.Analysis of the returned device was completed on 4/5/2024: the pump's event log was pulled as part of the investigation and upon review it was noted that two separate abrupt power offs were found in the log.An abrupt power off can be seen below on event line 508 by the "log_event_on" code without an "log_event_off" code before it.See complaint in question for detail of the event log.The mdr reportability of the complaint has been upgraded to "yes" after the discovery of the abrupt power off in the pump's event log history, which is mdr reportable the review of the event log did highlight several upstream occlusion alarms in the infusion history, 67 in total, as seen by the alarm code "e04".See complaint in question for detail of the event log.Functional testing did confirm the reported condition, but was not duplicated during testing.Reported issue found, device not performing to specification.Several capas has been opened in order to fully investigate and address the root causes of the reported events.

• Brand Name: NIMBUS II FLEX 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: 19112276
• Report Number: 3011581906-2024-00274
• Device Sequence Number: 12675456
• Product Code: FRN
• UDI-Device Identifier: 00817170020093
• UDI-Public: 00817170020093
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2024

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 FLEX
• Device Catalogue Number: NIMBUS II FLEX
• Device Lot Number: 170623-297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2017
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown