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

Model Number	NIMBUS II FLEX
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhr was reviewed, and the pump passed all previous tests.There are no previous complaints on this device.The pump was returned on 1/24/2024 and tested on 2/23/2024.The pump was tested with every step in it-004-wi-003 since the reported issue was unknown the results are below: the event log was reviewed, and it was found that there was an abrupt power off during an infusion.This is seen by the back to back log_event_on without a log_event_off on lines 30 and 31.Between them on lines 30 and 31.The pump then an 100 ml infusion and no other issues were found during testing.The reported unknown complaint is actually a power issue that was discovered during event log review.
Event or Problem Description
The original complaint had an unknown issue.However, the pump was returned on 1/24/2024 and tested on 2/23/2024.The evaluation finding was stated in section h10 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: 18784194
• Report Number: 3011581906-2024-00201
• Device Sequence Number: 15536981
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/26/2024

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: Health Professional
• Device Model Number: NIMBUS II FLEX
• Device Catalogue Number: NIMBUS II FLEX
• Device Lot Number: 210219600
• 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: Not provided
• Initial Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2021
• 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