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

Model Number NIMBUS II PLUS

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

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

Event Date 02/17/2024

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 02/17/2024, infutronix received a report that a pump had a flow rate issue-under infusion, causing loss of infusion parameters.The infusion cannot resume without causing delay in treatment.Requested device to be returned.

Event Description

On 2/17/2024, infutronix received report of a pump that had a flow rate issue and was "under infusing".The issue was found during testing, there was no patient involvement.The device was returned.

Manufacturer Narrative

Dhr was reviewed, and the pump passed all previous tests.There are no previous complaints on this device.Analysis of the returned device was completed on 3/20/2024: the device underwent functional testing and was unable to duplicate the reported condition.The device was tested with the testing protocol for flow rate, the initial bottle weight was recorded at 87.238 g before the 100 ml infusion, and 183.986 g after the infusion, which has a total volume of 96.748 ml and a deviation of -3.252 %.The pump is in range and is performing to specification.The device ran at a rate of 99 ml per hour and a vtbi of 100 ml, keeping the current customer's parameter for the rate.Reported issue not found, device performing to specification.The correction made was in section b5, the problem description was updated to reflect that the infusion parameters were never lost, it was only reported as under infusing.There was also no patient involvement, as it was discovered during testing.

• 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: frederick lee ; 177 pine street; natick, MA 01760 ; 5086502007
• MDR Report Key: 18759960
• MDR Text Key: 336012777
• Report Number: 3011581906-2024-00178
• 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: Health Professional,Company Representative,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NIMBUS II PLUS
• Device Catalogue Number: NIMBUS II PLUS
• Device Lot Number: 2208092040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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