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

Model Number NIMBUS II PLUS

Device Problems Failure to Power Up (1476); Complete Loss of Power (4015)

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024, infutronix received a report that a pump powered off on its own without warning, causing loss of infusion parameters.The infusion cannot resume without causing delay in treatment.Requested device 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 device involved or additional information becomes available.

Manufacturer Narrative

Dhr was reviewed, and the pump passed all previous tests.There are no previous complaints on this device.Upon review, the product was not returned.Analysis of the returned device was completed the pump was tested with the testing protocol for battery and power complaints.The pump's event log was pulled as part of the investigation and upon review it was noted that two abrupt power offs were found in the log, as reported by the end user.A 100 ml infusion was ran on the pump, using the pump's current parameters of 18.8 ml per hour.The infusion was unable to complete without the pump powering off, confirming the reported condition by the end user.A new battery was put into the pump and the battery level was reset.The same infusion was reran and the pump was able to complete successfully without powering off.This points to the root cause of the reported event to be a battery with an insufficient charge.Functional testing did confirm the reported condition and was duplicated during testing.Reported issue found, device not performing to specification.

• 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: 18582709
• MDR Text Key: 333823904
• Report Number: 3011581906-2024-00092
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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 Operator: Health Professional
• Device Model Number: NIMBUS II PLUS
• Device Catalogue Number: NIMBUS II PLUS
• Device Lot Number: 200604960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2020
• 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