MAUDE Adverse Event Report: INFUTRONIX, LLC 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	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump was received on april 10, 2024 investigation in process.This complaint will be reopened updated and a follow up report will be submitted once the investigation of the pump involved or additional information becomes available.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.A capa has been opened in order to fully investigate and address the root cause of the reported event.Reference to complaint (b)(4).
Event or Problem Description
On (b)(6) 2024, infutronix received a complaint stating that the pump had shut off and per completed recall return form pump returned.There were no other details provided.No patient involved injured/harm reported.

• 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: 19614737
• Report Number: 3011581906-2024-00601
• Device Sequence Number: 7167585
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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