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

Model Number	NIMBUS II PAINPRO
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
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.Analysis of the returned device was completed on 4/5/2024: the pump was tested with the testing protocol for infusion flow rate accuracy according to document # (b)(4).The initial bottle weight was recorded at 48.615 g before the 100 ml infusion, and 146.885 g after the 100 ml infusion, which has a total weight of (b)(4) g and a deviation of -1.73%.The pump is in range and is performing to specification, falling in the +- 5% range.The pump ran at a rate of (b)(4) per hour, an auto bolus set for every 5 hours, and a vtbi of 100 ml, keeping the current customer's parameter for the rate.The pump's event log was pulled as part of the investigation and upon review it was noted that several abrupt power offs were found in the log.An abrupt power off can be seen below on event lines 1, 2 and 3 by the "log_event_on" code without an "log_event_off" code before it: see complaint in question for event log detail information.The mdr reportability of the complaint has been upgraded to "yes" after the discovery of the abrupt power off in the pump's event log history, which is mdr reportable.Functional testing did not confirm the reported condition and was not duplicated during testing.Reported issue not found, but device not performing to specification due to abrupt ower off.Capas has been opened in order to fully investigate and address the root cause of the reported event.
Event or Problem Description
On 02/20/2024, infutronix received a report that a pump had an " pump - acts like it is running but is not infusing ".Patient was involved, but not harmed.Device was returned on 02/23/2024.Detail of the evaluation can be found in section h of this mdr.

• Brand Name: NIMBUS II PAINPRO 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: 19113073
• Report Number: 3011581906-2024-00230
• Device Sequence Number: 7651342
• Product Code: FRN
• UDI-Device Identifier: 00817170020086
• UDI-Public: 00817170020086
• Combination Product (Y/N): N
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2024

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 PAINPRO
• Device Catalogue Number: NIMBUS II PAINPRO
• Device Lot Number: 2202064320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2022
• 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