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

Model Number	NIMBUS II PLUS
Medical Device Problem Codes	Power Problem (3010); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
05/09/2024, infutronix medical received a report from a patient stating his pump was not working at all as the screen was not showing the numbers or anything.The patient mentioned it had beep earlier before calling, but had no idea what the alert might have been.Tech support had the patient look at the screenit and it was confirmed the patient was in the triation menu the pump had been paused and not running the infusion.The tech support assisted the patient to restart the pump and resume the infusion without further issues.No report of patient injury.
Additional Manufacturer Narrative
There is a previous complaint #(b)(4) on the device.Historical records were reviewed.It was discovered that there were discrepancies in the test records.Ncr #(b)(4) had been initiated to address the discrepancies.Device was received on 05/31/2024, investigation in process.This mdr will be reopened and updated once the investigation results are available.A capa has been opened in order to fully investigate and address the root cause of the reported event.Reference to complaint #(b)(4).
Additional Manufacturer Narrative
This complaint is being reopened for pump evaluation due to the device being received.There is another complaints on this device, see it2024n-1034.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 was an abrupt power off found in the log, as reported by the end user.An abrupt power off can be seen on event line 177 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 its own.It was noted that the pump was received without the original battery in it, which could have contributed to the malfunction reported and found in the log.A new battery was placed into the pump in order to complete evaluation.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.The infusion was ran using an hs-008 iv cassette with lot # 2304023 and expiration date (b)(6) 2026.Functional testing did confirm the reported condition, but was unable to be duplicated.Device does not meet specification.There was no clinical or impact health effects associated with this report.This complaint has been reviewed, evaluated, and determined to be a part of capa.Reference complaint # (b)(4).

• Brand Name: NIMBUS II PLUS AMBULATORY INFUSION PUMP
• Common Device Name: NIMBUS II PLUS 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: 19447971
• Report Number: 3011581906-2024-00592
• Device Sequence Number: 19643234
• Product Code: FRN
• UDI-Device Identifier: 00817170020161
• UDI-Public: 00817170020161
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: KD153193
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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 PLUS
• Device Catalogue Number: NIMBUS II PLUS
• Device Lot Number: 2202072880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Unknown