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

Model Number	NIMBUS II FLEX
Medical Device Problem Codes	Pressure Problem (3012); 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.The pump was received on 2/20/2024 and tested on 3/8/2024.The pump was received with a complaint form where the description states "pump began to beep several hours after pt left clinic.Stated there was an upstream occlusion.Assessed tubing with no kinks observed.All clamps were open.Flushed port line without any resistance", it occurred during treatment, and there was a delay that was explained by, "pt had to return to clinic to have a new pump applied delaying tx by about an hour".The initial code will change from 1unk1 to 1uos1 on 3/8/2024 from the information on the note.A picture of the note will be attached, see "304114 complaint form".The pump's event log will be pulled and reviewed in order to identify any possible upstream occlusion error codes.After reviewing the pump's event log, 36 upstream occlusions were found in the log, as seen on 128, as highlighted by the "e04" code.See complaint in question for detail of event log description.After reviewing the pump's event log, an abrupt power off was found on event line 128, 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 of event log description.Issue reportability was changed to reportable after the complaint was submitted, which is why the complaint has been updated to reportable, due to the complaint code "2pow3: power issue - device powers self off" being mdr reportable according to protocol 6.Due to the need for a new pump reported in the complaint form and an abrupt power off found in the event log, this has caused the reportability to be changed to "yes" for the complaint.Issues of upstream occlusion and abrupt power off were found, device not performing to specification.
Event or Problem Description
On 01/31/2024, infutronix received a report that a pump had " occlusion sensor- constant nuisance alarm".The infusion cannot resume without causing delay in treatment.The pump was received on 2/20/2024 and tested on 3/8/2024.Issues of upstream occlusion and abrupt power off were found, device not performing to specification.No patient harmed.Detail of the evaluation was 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: 18903598
• Report Number: 3011581906-2024-00245
• Device Sequence Number: 12722436
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2024

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: 200114300
• 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: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2020
• 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