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

Model Number	NIMBUS II PLUS
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Pump was returned on 5/10/2024 and evaluated.The mdr reportability of this complaint was being upgraded to "yes", as the abrupt power off found in the event log review was determined to be reportable according to the updated mdr decision tree guide.Patient was involved, but not harmed.
Additional Manufacturer Narrative
This complaint record was being reopened for device evaluation due to the device being returned on 05/10/2024.The historical test records were reviewed in the qos system.The device had passed all tests.There are no previous complaints on this device.Complaint evaluation was completed on 5/17/2024.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, which help explain the reported condition by the end user, as the pump lost its battery and powered off.An abrupt power off can be seen below 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.Upon further evaluation there were no loose connections or components inside of the device, which could have contributed to the reported malfunction and the instances found in the event log.Functional testing did confirm the reported condition but was unable to be duplicated during testing.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.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 PLUS 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: 19376110
• Report Number: 3011581906-2024-00578
• Device Sequence Number: 12667277
• Product Code: FRN
• UDI-Device Identifier: 00817170020161
• UDI-Public: 00817170020161
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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 PLUS
• Device Catalogue Number: NIMBUS II PLUS
• Device Lot Number: 200604960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2020
• 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