MAUDE Adverse Event Report: INFUTRONIX, LLC NIMBUS II FLEX AMBULATORY INFUSION PUMP; 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	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.Pump received on 2/20/2024 and tested on 3/8/2024.Due to the abrupt power off reported in the complaint form, this has caused the reportability to be changed to "yes" for the complaint due to the initial complaint code change.Pump was given the initial complaint code of "2pow3: power issue - device powers self off" instead of "1unk1: unknown issue - unknown issue from customer.Mdr report: no".The pump's event log will be pulled and reviewed in order to identify any possible abrupt power off errors.After reviewing the pump's event log, an abrupt power off was found on event line 66, as highlighted by the "log_event_on" code without a "log_event_off" before it, meaning that the pump had to be powered back on without being powered off.See complaint in question for detail.Reported issue of abrupt power was found, device not performing to specification.
Event or Problem Description
On 01/31/2024, infutronix received a report that a pump powered off on its own without warning, causing loss of infusion parameters.The infusion cannot resume without causing delay in treatment.No patient harmed.The pump was returned on 2/20/2024 and was tested on 3/8/2024.Detail of the findings are available 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: 18891610
• Report Number: 3011581906-2024-00258
• Device Sequence Number: 7505244
• 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: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2024

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: 190910360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2019
• 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