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

Model Number	NIMBUS II PLUS
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/06/2023, infutronix received a report that the pump kept shutting off.There was no patient injury reported.Subsequent information received on 06/07/2023 indicated the medication to be infused was fluorouracil at a volume of 92ml.However, there was a delay in therapy since the pump would automatically shut off without an audible sound or visible error message, and the infusion could not be started.The pump in question was set aside, and the therapy was successfully administered with another pump.The pump in question was not available for return at the initial time that the event was reported, and the complaint file was closed.On 05/17/2024, the pump was returned to infutronix for evaluation with reference to this event.The reportability decision was re-evaluated and determined to be 30-day reportable to fda.
Additional Manufacturer Narrative
A complaint evaluation was performed on 28-may-2024.A review of the pump's system error log found there were several abrupt power offs error messages in the log.These power off error messages were verified in the event log under event line 62 by the following codes: log event on and log event off.Testing of the returned pump simulating the user's parameters for a 46-hour infusion with a volume of 100ml at a rate of 2.2 ml set up had a successful infusion completion without abrupt shut offs.There were no other visual anomalies found that could have contributed to the reported issue.The reported power off issue was confirmed via device event log, but the issue could not be duplicated during the complaint evaluation testing.A capa has been established to investigate this failure mode to determine the root cause.

• Brand Name: NIMBUS II PLUS AMBULATORY INFUSION PUMP
• Common Device Name: AMBULATORY INFUSION PUMP
• Manufacturer (Section D): INFUTRONIX, LLC; 177 pine street; natick MA 01760 1331
• Manufacturer (Section G): INFUTRONIX, LLC; 177 pine street; natick MA 01760 1331
• Manufacturer Contact: frederick lee ; 177 pine street; natick, MA 01760-1331 ; 5086502008
• MDR Report Key: 19548226
• Report Number: 3011581906-2024-00590
• Device Sequence Number: 17327157
• Product Code: FRN
• UDI-Device Identifier: 00817170020161
• UDI-Public: 00817170020161
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/17/2024

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 PLUS
• Device Lot Number: 210325960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1285-2024
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Unknown