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

Model Number NIMBUS II FLEX

Device Problems Mechanical Problem (1384); No Flow (2991)

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

Event Date 02/01/2024

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 02/01/2024, infutronix received a report that a pump stopped infusing due to a system error alert.The infusion cannot resume without causing delay in treatment.Requested device to be returned.

Manufacturer Narrative

The event log was reviewed and confirms that the pump alarmed system error during an infusion.This is seen on lines 557, 558, 561 and 562.There are multiple subcodes for the system error.24 indicates motor is fast, motor delay issue.44 indicates motor open, motor delay issue.Event 557: log_event_alarm time: 08:50:47 alarm code: 02 sub code: 24 alarm status: log_alarm_cause_ack_alarm eventbytes: 05 50 47 02 24 00 31 f3.Event 558: log_event_alarm time: 08:51:07 alarm code: 02 sub code: 24 alarm status: log_alarm_cause_exit_to_prog eventbytes: 05 51 07 02 24 00 32 b5.Event 561: log_event_alarm time: 08:52:09 alarm code: 02 sub code: 44 alarm status: log_alarm_cause_ack_alarm eventbytes: 05 52 09 02 44 00 31 d7.Event 562: log_event_alarm time: 08:52:15 alarm code: 02 sub code: 44 alarm status: log_alarm_cause_exit_to_prog eventbytes: 05 52 15 02 44 00 32 e4.A performance test was done on the pump where an 100 ml infusion was started, and the pump alarmed system error 3 ml's into the infusion.The reported issue is confirmed.The pump does not meet passing criteria.

• Brand Name: NIMBUS II FLEX 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: 18637506
• MDR Text Key: 334543681
• Report Number: 3011581906-2024-00123
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NIMBUS II FLEX
• Device Catalogue Number: NIMBUS II FLEX
• Device Lot Number: 200114300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2020
• 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