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

Model Number	NIMBUS II FLEX
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhr was reviewed, and the pump passed all previous tests.There are no other complaints on this device.Evaluation of the returned device was completed on 4/29/2024: 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 it was noted that the pump underwent two system error alarms, as reported by the end user, which can be seen by the "e02" alarm code.The alarm code 02 for system error was followed by sub code "44" which means, "motor open" and "motor delay issue" and was the cause for the system error to alarm.A 102 ml infusion was ran on the pump instead of a 100ml infusion as the end user's current parameters were kept.The pump ran a 102 ml infusion over 46 hours and was able to complete without alarming system error.Functional testing did confirm the reported condition and was not duplicated during testing.Reported issue found, device not 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
On 01/31/2024, 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 was involved.The device was returned on 02/15/2024 for further evaluation.Detail of the 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: 19225253
• Report Number: 3011581906-2024-00482
• Device Sequence Number: 8105619
• Product Code: FRN
• UDI-Device Identifier: 00817170020093
• UDI-Public: 00817170020093
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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: Other
• Device Model Number: NIMBUS II FLEX
• Device Catalogue Number: NIMBUS II FLEX
• Device Lot Number: 170622-027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2017
• 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