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

Model Number NIMBUS II PAINPRO

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

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

Event Date 02/07/2024

Event Type  malfunction  

Event Description

On 02/07/2024, infutronix received a report that a pump stopped infusing due to a system error alert.The infusion cannot resume without causing delay in treatment.No patient harmed.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 70, 71, 75 and 76.There are multiple subcodes for the system error.24 indicates motor is fast, motor delay issue.44 indicates motor open, motor delay issue.Event 70: log_event_alarm time: 03:48:113 alarm code: 02 sub code: 44 alarm status: log_alarm_cause_ack_alarm eventbytes: 05 48 b3 02 44 00 31 77 event 71: log_event_alarm time: 03:48:113 alarm code: 02 sub code: 44 alarm status: log_alarm_cause_exit_to_prog eventbytes: 05 48 b3 02 44 00 32 78 event 75: log_event_alarm time: 03:48:113 alarm code: 02 sub code: 24 alarm status: log_alarm_cause_ack_alarm eventbytes: 05 48 b3 02 24 00 31 57 event 76: log_event_alarm time: 03:48:113 alarm code: 02 sub code: 24 alarm status: log_alarm_cause_exit_to_prog eventbytes: 05 48 b3 02 24 00 32 58 a performance test was done on the pump where an 100 ml infusion was started, and the pump alarmed system error immediately during the infusion.The reported issue is confirmed.The pump does not meet passing criteria.

• Brand Name: NIMBUS II PAINPRO 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: 18877575
• MDR Text Key: 337796137
• Report Number: 3011581906-2024-00144
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00817170020086
• UDI-Public: 00817170020086
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NIMBUS II PAINPRO
• Device Catalogue Number: NIMBUS II PAINPRO
• Device Lot Number: 2202064320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2022
• 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