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

Model Number NIMBUS II PLUS

Device Problems Mechanical Problem (1384); Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record has been completed.The pump passed all previous tests.Complaint data was reviewed, there are no previous complaints on this device.Device return requested.

Event Description

On 03/04/2024, infutronix received a report that a pump stopped infusing due to a system error alert.The infusion cannot resume without causing delay in treatment.No patient harmed.Requested device to be returned.

Manufacturer Narrative

Upon review of the reported event it was noted that the incorrect pump serial number was given by the end user, and the pump mentioned in the initial filing is not accurate.The brand name and common device names, as well as the model, catalog, serial, udi and lot numbers in section d were all corrected to reflect that the pump involved's exact information was not known.The initial serial number reported by the end user, and included in the initial filing, was found to never have been shipped out by the manufacturer and was never used.It was also noted that the initial complaint code given to the complaint was incorrect.Once the correct code was put in the complaint it was noted that the complaint was not reportable based on the end user's report.A capa has been opened in order to fully diagnose and address the root cause of the reported event.[reference complaint # (b)(4).

• Brand Name: NIMBUS II PLUS AMBULATORY INFUSION PUMP
• Type of Device: 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: 18946969
• MDR Text Key: 338192702
• Report Number: 3011581906-2024-00323
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00817170020161
• UDI-Public: 00817170020161
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NIMBUS II PLUS
• Device Catalogue Number: NIMBUS II PLUS
• Device Lot Number: 2206012640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1