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

Model Number	NIMBUS II PLUS
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Infutronix received a report that the pump had an immediate power off.There were no other details provided.The exact date of the event was not provided.There was no patient injury reported.Multiple requests for additional information were made, including a request to return the pump for evaluation.
Additional Manufacturer Narrative
On 13-jun-2024, a complaint investigation was initiated for this pump which included, but is not limited to, visual and functional testing per internal protocol by the complaint evaluation specialist to investigate the reported power off issue.The investigation is ongoing, and a conclusion is not yet available.A follow-up report will be submitted upon completion of the product investigation.

• 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 1331
• Manufacturer (Section G): INFUTRONIX, LLC; 177 pine street; natick MA 01760 1331
• Manufacturer Contact: frederick lee ; 177 pine street; natick, MA 01760-1331 ; 5086502008
• MDR Report Key: 19736023
• Report Number: 3011581906-2024-00605
• Device Sequence Number: 15233229
• Product Code: FRN
• UDI-Device Identifier: 00817170020161
• UDI-Public: 00817170020161
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/12/2024

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: Health Professional
• Device Model Number: NIMBUS II PLUS
• Device Catalogue Number: NIMBUS J
• Device Lot Number: 200417282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2020
• 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