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

Model Number	NIMBUS II PAINPRO
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were two changes in the correction of tis mdr.The first is e2: health professional, it was changed to yes.The second change was in g3: date received by manufacturer.It should be 04/18/2024 instead of 05/16/2022.
Additional Manufacturer Narrative
A review of the device history record has been completed.The pump passed all previous tests.Complaint data was reviewed, there are no previous complaints on this device.The pump was received on 2/22/2024.Analysis of the returned device was completed on 4/18/2024: upon pump power up to pull the event log, the pump began to alarm system error immediately.The reported issue was confirmed.The event log was then unable to be pulled due to limitations with the tool for h pumps at the time.The reported condition was reproduced 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.This mdr will be reopened and updated in the event the device involved or additional information becomes available.
Event or Problem Description
The first and original date of initial contact of this complaint was 05/16/2022 and it was not a reportable event.No patient was harmed.The device was returned on 02/22/2024 for further evaluation.On 04/18/2024, infutronix investigated on the returned device and discovered it had an issue of alarm system error which was reportable.

• 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: 19194043
• Report Number: 3011581906-2024-00552
• Device Sequence Number: 18052425
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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 PAINPRO
• Device Catalogue Number: NIMBUS II PAINPRO
• Device Lot Number: 2111242568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown