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

Model Number NIMBUS II PLUS

Device Problem False Alarm (1013)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Building service coordinator reported "upstream while testing down".No patient involvement.

Manufacturer Narrative

A review of the device history record has been completed.This pump passed all previous tests.Complaint history review performed.No previous complaints on this device.Analysis of the returned device is complete.Results: the event log for nimbus ii plus, serial number (b)(6), was reviewed, and it was discovered that the pump logged an upstream occlusion error during a patient's infusion.But the test was then performed on the nimbus ii plus serial number (b)(6) where the pump displayed the downstream occlusion error message when there was blocking in the downstream line, and the pump delivered normally once the block was removed.The reported complaint of an upstream occlusion issue was confirmed in the event log, but the performance test did not repeat the reported complaint.The pump was found to be operating inside the specification and the pump meets the passing criteria.

• 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 ; 5083158230
• MDR Report Key: 16838462
• MDR Text Key: 314273038
• Report Number: 3011581906-2023-00066
• 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: Other,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NIMBUS II PLUS
• Device Lot Number: 2111081200
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2021
• 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