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

Model Number	N/I
Medical Device Problem Code	Problem with Software Installation (3013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhr was reviewed, and the pump passed all previous tests.There are no previous complaints on this device.Complaint type (category): clinician code issue event log extraction details: event log shows several attempts to edit parameters.Event log reflect reported issue? (y/n, why): yes.Pump was turned off and on multiple times, as well as attempts to program the pump.Shows the issue reported.Investigation results: reported issue was found right away.After typing in the clinician code, could not edit parameters or start an infusion.It would just keep returning me to the menu to type in the clinician code.Testing conclusion: final conclusion: confirmed cause of the issue is not determined.Returned complaint devices are not here or recertified post-investigation.Intended library: unknown.A capa has been opened in order to fully diagnose and address the root cause of the reported event.
Event or Problem Description
On (b)(6) 2020 a complaint was opened in qos where intuvie received a complaint that the pump has incorrect library configuration.There is an user interface issue where after typing in the clinician code they couldn't edit the parameters and couldn't start an infusion.The screen just goes back asking again and again to enter the clinician code.No other details were provided associated with the event.No patient harm was reported in this complaint.

• Brand Name: NIMBUS G 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: 19094219
• Report Number: 3011581906-2024-00441
• Device Sequence Number: 7705342
• Product Code: FRN
• UDI-Device Identifier: 00817170020093
• UDI-Public: 00817170020093
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2024

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: N/I
• Device Catalogue Number: N/I
• Device Lot Number: 170623297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 04/11/2024
• 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