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

Model Number	NIMBUS H
Medical Device Problem Code	Problem with Software Installation (3013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/19/2021, a complaint was opened in qos intuvie received a complaint that the pump has incorrect library configuration.Unreleased version 4 duke protocol library installed on the nimbus painpro (h) pump by the customers' service provider instead of the intended duke v3 protocol library.No other details were provided associated with the event.No patient harm was reported in this complaint.
Additional Manufacturer Narrative
Infutronix issued a product quality hold order to verify all the products in the inventory are free from similar issues.Three customer letters were sent to affected customers (b)(6) health.Unreleased version 4 duke protocol library installed on the nimbus painpro (h) pump by the customers' service provider instead of the intended duke v3 protocol library.Infutronix issued a health hazard evaluation.Infutronix issued a field action plan to address this issue.This field action will replace the affected infusion pump with pumps installed with the correct duke v3 protocol library.Dhr was reviewed, and the pump passed all previous tests.Returned complaint devices are not available as of 4/12/2024 or recertified post-investigation.Intended library: duke v3.Actual library: duke v4 (unreleased).Both versions of the duke library share the same clinician code "191".The device was operable by the user.

• Brand Name: NIMBUS H 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: 19095245
• Report Number: 3011581906-2024-00528
• Device Sequence Number: 7858724
• Product Code: FRN
• UDI-Device Identifier: 00817170020086
• UDI-Public: 00817170020086
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

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
• Device Model Number: NIMBUS H
• Device Catalogue Number: NIMBUS H
• Device Lot Number: 2009231440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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