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

Model Number NIMBUS II FLEX PUMP

Device Problems Failure to Power Up (1476); Insufficient Flow or Under Infusion (2182)

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

Event Date 07/17/2023

Event Type  malfunction  

Event Description

Healthcare professional reported an error with pump 301659 while connected to patient.The error caused an under infusion for the patient of 13 ml of medication.During the troubleshooting of the device, the nurse asked for the pump to be turned off and then back on and at that time, the pump wouldn't power back on.Also, a note was discovered stating that an upstream occlusion alarm may have occurred.Medications being infused is unknown.No patient injury reported.

Manufacturer Narrative

Return of the device has been requested.As of the date of this report, device has not been returned.

Manufacturer Narrative

A review of the device history record has been completed.This pump passed all previous tests.Complaint data was reviewed, there are no previous complaints on this device.Event log was reviewed and confirms the abrupt loss of power.

• 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: lorraine hanley ; 177 pine street; natick, MA 01760 ; 5086502007
• MDR Report Key: 17556626
• MDR Text Key: 321417435
• Report Number: 3011581906-2023-00138
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00817170020093
• UDI-Public: 00817170020093
• 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
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

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: Lay User/Patient
• Device Model Number: NIMBUS II FLEX PUMP
• Device Catalogue Number: NIMBUS II FLEX PUMP
• Device Lot Number: 180517720
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2017
• 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