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

Model Number	NIMBUS II FLEX
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/14/2024, infutronix received a report that a pump had a system error - alarm during infusion.Patient calling in because their pump was alarming system error at them.No patient was not harmed.Device was requested to be returned.
Additional Manufacturer Narrative
The historical test records were reviewed in the qos system.All test results relevant to the reported issue had passed.There was no previous complaint on this device.This mdr will be reopened and updated in the event the product involved or additional information becomes available.A capa had been opened in order to fully investigate and address the root causes of the reported events after the evaluation.Reference to complaint # (b)(4).
Additional Manufacturer Narrative
On 03-jul-2024, this pump underwent visual, physical, and functional testing per internal protocol by the complaint evaluation specialist to investigate the reported alarming system error.The visual/physical analysis did not find any anomalies and verified the pump's library was configured properly.Review of the device error log confirmed the reported system error alarm (e02).Review of the pump's recertification records found testing passed successfully.The functional testing confirmed the reported issue based on simulated customer parameters for a 24-hour infusion.Note: this pump is included in recall # z-1285-2024 as noted in sections and therefore further individual investigation was not deemed required.
Event or Problem Description
On 06-jun-2024, infutronix received the pump which was previously requested to be returned for investigation.

• 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: 19363502
• Report Number: 3011581906-2024-00583
• Device Sequence Number: 19782848
• Product Code: FRN
• UDI-Device Identifier: 00817170020093
• UDI-Public: 00817170020093
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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 FLEX
• Device Catalogue Number: NIMBUS G
• Device Lot Number: 170829-240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1285-2024
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Unknown