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

Model Number NIMBUS II FLEX

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 03/30/2023

Event Type  malfunction  

Event Description

A distributor received information from a product complaint analyst at infusystem that a patient called the after-hours hotline, 6:23 am, to report the medication bag had fully infused.The patient indicated the bag emptied about 6 hours too early.The patient also indicated to the analyst that the pump had alarmed upstream occlusion.The pump volume to be infused was 100ml, and the rate was 46 hours.Volume delivered: 100ml volume remaining: 0ml".Customer support sent follow-up questions to the reporter.The reporter indicated there was no patient harm, provided the serial number of the pump, the date of the issue, and the medication.Patient involved.There was no harm to the patient.No further details were provided.The medication was 5fu.

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.Results: 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 flex, serial number (b)(6), was reviewed, and it was discovered that the event log does not capture the upstream occlusion error.Then the test was performed on the nimbus ii flex, serial number (b)(6), where the pump flow rate accuracy resulted in +0.021% within the passing criteria specifications.The reported complaint was not confirmed in the event log and was not repeated in the performance test.The pump was found to be operating inside the specification.

• 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: 16831216
• MDR Text Key: 314169808
• Report Number: 3011581906-2023-00054
• 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: Other,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

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: Lay User/Patient
• Device Model Number: NIMBUS II FLEX
• Device Lot Number: 190527480
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2019
• 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