MAUDE Adverse Event Report: INFUTRONIX, LLC NIMBUS II PAINPRO

Model Number NIMBUS II PAINPRO

Device Problems Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)

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

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

Dhr was reviewed, and the pump passed all previous tests.There are no previous complaints on this device.Pump received 2/22/2024 and tested on 2/23/2024.Pump was given the initial complaint code of "2pum1: pump - acts like it is running but is not infusing", but the reportability was changed to "yes" since the patient was reported to have gotten no relief from the pump.Pump was tested with the following infusion flow rate accuracy testing procedure from document (b)(4).The pump was measured to have a flow rate deviation of 5.2 % which out of specification.Reported issue found, device not performing to specification.

Event Description

On 02/16/2024, infutronix received a report that a pump ' acts like it is running but is not infusing", causing loss of infusion parameters.The infusion cannot resume without causing delay in treatment.Pump received 2/22/2024 and tested on 2/23/2024.See section h10 of this mdr for the detail finding.

• Brand Name: NIMBUS II PAINPRO
• Type of Device: NIMBUS II PAINPRO
• 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: 18799162
• MDR Text Key: 337627710
• Report Number: 3011581906-2024-00269
• Device Sequence Number: 1
• Product Code: FRN
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• 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: 211121360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2021
• 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