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 01/23/2024

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

Event Description

On 01/23/2024, infutronix received a report that a pump stopped infusing due to a system error alert.The infusion cannot resume without causing delay in treatment.Requested device to be returned.

Manufacturer Narrative

Dhr was reviewed, and the pump passed all previous tests.There are no other complaints on this device.The pump was received on (b)(6)2024 and tested on (b)(6)2024.The results are below: the pump's event log was reviewed, and it confirms that there was a system error during an infusion.It took place during a demand bolus delivery.This is seen on line 97 "alarm code: 02 sub code: 24." the subcode indicates motor is fast, motor delay issue.Attempted to resume the infusion that was running on the pump, and it alarmed system error immediately.The reported issue is confirmed.The pump does not meet passing criteria.

• Brand Name: NIMBUS II PAINPRO AMBULATORY INFUSION PUMP
• Type of Device: AMBULATORY INFUSION PUMP
• Manufacturer (Section D): INFUTRONIX, LLC; 177 pine street; natick 01760
• Manufacturer (Section G): INFUTRONIX, LLC; 177 pine street; natick 01760
• Manufacturer Contact: frederick lee ; 177 pine street; natick 01760 ; 5086502007
• MDR Report Key: 18617231
• MDR Text Key: 334848179
• Report Number: 3011581906-2024-00072
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

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 Model Number: NIMBUS II PAINPRO
• Device Catalogue Number: NIMBUS II PAINPRO
• Device Lot Number: 2202064320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2022
• 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