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

Model Number NIMBUS II PLUS

Device Problems Mechanical Problem (1384); No Flow (2991)

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

Event Date 12/26/2023

Event Type  malfunction  

Event Description

On 01/02/2024, infutronix received a report that this pump has had a system error, which could cause delay in treatment.Device was requested to be returned.

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.This mdr will be reopened and updated in the event the product involved or additional information becomes available.

Event Description

On 01/02/2024, infutronix received a report that this pump has had a system error, which could cause delay in treatment.

Manufacturer Narrative

Dhr was reviewed, and the pump passed all previous tests.There are no previous complaints on this device.The pump was tested with the testing protocol for system error alarm / motor function.A 20 ml infusion was ran on the pump instead of 100 ml due to the customer's library on the pump, using the current parameters of 20 ml at 0.5 ml per hour.When the infusion began the pump immediately powered off abruptly.A new battery was put into the pump and the battery level on the pump was reset to further diagnose the pump.The infusion was restarted and the pump immediately began to alarm "system error", confirming the reported issue.A capa has been opened in order to fully investigate and address the root causes of the reported event.

• Brand Name: NIMBUS II PLUS AMBULATORY INFUSION PUMP
• Type of Device: AMBULATORY INFUSION PUMP
• Manufacturer (Section D): INFUTRONIX, LLC; 177 pine st; natick MA 01760
• Manufacturer (Section G): INFUTRONIX, LLC; 177 pine st; natick MA 01760
• Manufacturer Contact: frderick lee ; 177 pine st; natick, MA 01760 ; 5086502007
• MDR Report Key: 18474805
• MDR Text Key: 333093386
• Report Number: 3011581906-2024-00002
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NIMBUS II PLUS
• Device Catalogue Number: NIMBUS II PLUS
• Device Lot Number: 2208092040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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