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); Complete Loss of Power (4015)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

On 02/23/2024, infutronix received a report that a pump had a "flow rate issue- not infusing", causing loss of infusion parameters.The infusion cannot resume without causing delay in treatment.Requested device to be returned.

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 2/23/2024, infutronix received report of a pump that powered off on it's own without warning.The infusion cannot resume without causing delay in treatment.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 3/19/2024: the pump's event log was pulled and reviewed, which highlighted an abrupt power off, as reported by the end user.The code "log_event_on" code was found without an "log_event_off" code before it points to the abrupt power off as it means that the pump had to be powered on without being powered off prior, meaning that it turned off on it's own.In order to further verify the abrupt power off, the pump was tested with the testing protocol for battery and power complaints: the pump was powered on and only the option for "new infusion" was available, which further confirms the abrupt power off.The pump was ran at 1 ml per hour for 1000 vtb over 96 hours, but the pump ended up powering off shortly after being started.A new battery was put into the pump and then a battery reset was done.The infusion was restarted and finished with no abrupt power offs taking place.Reported issue found, device not performing to specification.The root cause is a depleted battery.The corrections made were in sections b5, the problem desscription was updated to reflect the complaint being for abrupt power off, not a flow rate issue.The medical device problem codes in section h6 were also updated for this same reason, the reported problem was for a power off which is not related to the infusion rate.

• 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: fred lee ; 177 pine street; natick, MA 01760 ; 5086502007
• MDR Report Key: 18804582
• MDR Text Key: 337624114
• Report Number: 3011581906-2024-00205
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

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 PLUS
• Device Catalogue Number: NIMBUS II PLUS
• Device Lot Number: 2206213120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• 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