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

Model Number	NIMBUS II FLEX
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reopened due to the device being received for evaluation.Dhr was reviewed, and the pump passed all previous tests.There are no other complaints on this device.Upon review of this complaint type and investigation of the device, it was noted that the initial complaint code's reportability has since been upgraded to "yes" according to protocol 6 since the creation of the complaint and will be updated.Analysis of the returned device was completed on 4/17/2024: the pump was tested with the testing protocol for system error alarm / motor function.The pump's event log was pulled as part of the investigation and upon review it was noted that there was no record of the pump running any infusion.The reported event occurred on 10/14/2020 and the pump was sent for recertification on 10/23/2020 without being evaluated, which completely wiped out the event log.Upon review of the pump's dhr it appeared to pass all tests and does not show any failures from the recertification process.A 100 ml infusion was ran on the pump over 24 hours at a rate of 4.2 ml per hour.The infusion successfully completed and the pump did not power off abruptly before finishing or have any "system error" alarms.Upon further investigation there were no loose connections or components inside of the device.Functional testing did not confirm the reported condition and was not duplicated during testing.Reported issue not found, device performing to specification.A capa has been opened in order to fully investigate and address the root cause of the reported event.
Event or Problem Description
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 was harmed.Device was returned on 02/22/2024 for further evaluation.See section h of this mdr for detail of the evaluation.

• 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: 19205180
• Report Number: 3011581906-2024-00449
• Device Sequence Number: 15466009
• Product Code: FRN
• UDI-Device Identifier: 00817170020093
• UDI-Public: 00817170020093
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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: 171027180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2017
• 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