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

Model Number	NIMBUS II PAINPRO
Medical Device Problem Code	Problem with Software Installation (3013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of product complaint history confirmed there are no other complaints associated with this device.Review of the dhr confirmed this device passed all previous tests and inspections.Upon review there is indication in the dhr the pump was loaded with the unreleased version of the customer's library, confirming the reported event by the end user.The device has been evaluated to confirm the issue of the incorrect library configuration.There has been a capa opened to further investigate this complaint type.
Event or Problem Description
On 10/15/2021 vann griffin of infutronix solutions was notified by richard sapienza.Cardinal health reported that the pump had the incorrect library configuration duke v4 instead of duke v3.Medication n/a.No patient involved.No patient was harmed.Device is being returned.

• Brand Name: NIMBUS II PAINPRO AMBULATORY INFUSION PUMP
• Common Device Name: NIMBUS II PLUS 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: fred lee ; 177 pine street; natick 01760
• MDR Report Key: 19101394
• Report Number: 3011581906-2024-00508
• Device Sequence Number: 15271009
• Product Code: FRN
• UDI-Device Identifier: 00817170020086
• UDI-Public: 00817170020086
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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 PAINPRO
• Device Catalogue Number: NIMBUS II PAINPRO
• Device Lot Number: 2009231440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (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