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

Model Number	NIMBUS II FLEX
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Additional 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.Pump received on 1/24/2024 and tested on 3/4/2024.The pump was given the initial complaint code of "1unk1: unknown issue - unknown issue from customer" due to the pump being reported to beep, but there is no specific reason pointed to.According to the nimbus ii series complaint investigation process work instruction with document # it-004-wi-003, any pump with an "unknown issue" complaint is to be evaluated for all acceptance criteria as defined in the work instruction, with any failures being documented.The pump's event log was also pulled and reviewed, as defined in the work instruction.After reviewing the pump's event log, an abrupt power off was found, including one shown here on event line 625, as highlighted by the "log_event_on" codes without a "log_event_off" before it, meaning that the pump had to be powered back on without being powered off.See the complaint in question for detail information.Due to the abrupt power off found during the event log review, this has caused the reportability to be changed to "yes" for the complaint.The pump ended up failing the flow rate test.The initial bottle weight of the pump was recorded at 48.141 g and the final weight after the 100ml infusion was measured at 141.889 g.This means the pump infused 93.748 ml out of 100 ml which is a deviation of -6.252% which is out of specification.Issues of abrupt power and flowrate were found, device not performing to specification.
Event or Problem Description
Infutronix received a report that a pump had an 'unknown issue ".Pump received on 1/24/2024 and tested on 3/4/2024.Detail of the device evaluation can be found in section h of this mdr.

• Brand Name: NIMBUS II FLEX AMBULATORY INFUSION PUMP
• Common Device Name: 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: 18882897
• Report Number: 3011581906-2024-00318
• Device Sequence Number: 19601596
• Product Code: FRN
• UDI-Device Identifier: 00817170020093
• UDI-Public: 00817170020093
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K153193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: NIMBUS II FLEX
• Device Catalogue Number: NIMBUS II FLEX
• Device Lot Number: 180517720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown