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

Model Number	NIMBUS II FLEX
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/31/2024, infutronix received a report that a pump stopped infusing due to a system error alert.The infusion cannot resume without causing delay in treatment.No patient injury.Device was returned on 02/20/2024.Detail of the evaluation was in section h of this mdr.
Additional Manufacturer Narrative
A review of the device testing record has been completed.The pump passed all previous tests.Complaint data was reviewed, there are no previous complaints on this device.Evaluation of the returned device was completed on 5/3/2024: the pump was received with software version number 5.6.2 and library configuration "ch-nwa - v2".The pump was tested with the testing protocol for system error alarm / motor functions.The pump's event log was pulled as part of the evaluation and upon review it was noted that there was evidence of several system error alarms in the pump's event log, 2 in total, as seen by the "e02" alarm code.The e02 alarm codes were followed by sub code "44" which means "motor open" and "motor delay issue", and points to the root cause of the system error alarm.A 100 ml infusion was ran on the pump using the end user's current parameters of 100 ml over 48 hours, with a rate of 2.1 ml per hour.The infusion was able to successfully complete and the pump did not alarm system error after the infusion began.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.Functional testing did confirm the reported condition and was not duplicated during testing.Reported issue found, device does not meet specification.A capa has been opened in order to fully investigate and address the root cause of the reported event.This mdr will be reopened and updated in the event the device involved or additional information becomes available.[reference: complaint # (b)(4).

• 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: 19267635
• Report Number: 3011581906-2024-00566
• Device Sequence Number: 7494799
• Product Code: FRN
• UDI-Device Identifier: 00817170020093
• UDI-Public: 00817170020093
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2024

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: Other
• Device Model Number: NIMBUS II FLEX
• Device Catalogue Number: NIMBUS II FLEX
• Device Lot Number: 170621-081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/08/2024
• 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