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

Model Number NIMBUS II PAINPRO

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

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

Event Date 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

Dhr was reviewed, and the pump passed all previous tests.There are two previous complaints on this device, see complaint # (b)(4) which this is an extension of, and then see complaint # (b)(4) in qos which evaluates the second reported issue in the same case.This complaint was originally opened in cq as complaint # (b)(4), which was closed under "device not returned".The pump has since been returned and will be evaluated underneath this new complaint that was opened.Refer to the attachment "(b)(4) ~ salesforce - enterprise edition" for all information on the previous complaint.This complaint is being opened to evaluate the reported system error, see complaint # (b)(4) for the reported abrupt power off evaluation.The pump was received on 1/22/2024 and was evaluated on 3/6/2024.This complaint was given the initial complaint code of, "2sys1: system error - alarm during infusion", where there was a system error alarm reported during the infusion.Pump was tested with the following testing protocol for system error according to the nimbus ii series complaint investigation process work instruction with document # (b)(4).See work instruction for detail.The pump failed the testing protocol as upon powering on the pump immediately began to alarm "system error".There was no infusion needed, the pump began to alarm on its own without any buttons pressed.The pump was opened up and evaluated for any loose connections but none could be found.Reported issue of system error was found, device not performing to specification.

Event Description

On 08/03/2023, infutronix received a report that a pump stopped infusing due to a system error alert-alarm during infusion.The infusion cannot resume without causing delay in treatment.No patient harm.Device was returned 0n 01/22/2024 and was evaluated on 3/6/2024.The detail of the evaluation can be found in section h of this mdr.

• Brand Name: NIMBUS II PAINPRO 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: 18885377
• MDR Text Key: 337746617
• Report Number: 3011581906-2024-00328
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00817170020086
• UDI-Public: 00817170020086
• 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,Company Representative,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NIMBUS II PAINPRO
• Device Catalogue Number: NIMBUS II PAINPRO
• Device Lot Number: 211122360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2021
• 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