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

Model Number	NIMBUS 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	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are no previous complaints on this device.The historical test records were reviewed in the qos system.All test results relevant to the reported issue have passed.Manufacturing final testing was completed on 9/27/2019 and service testing was completed on 12/24/2021.The pump was requested for recertification on 5/14/2021 and the recertification was finished on 1/31/2022.The pump was received with software version number 5.8.0 and library configuration "ch cci - v1".The pump was tested with the testing protocol for system error alarm / motor functions.The pump's event log was pulled as part of the investigation and upon review it was noted that there was evidence of two system error alarms in the pump's event log, as reported by the end user.The system error alarm is represented the "e02" alarm code.A 100 ml infusion was ran on the pump using the end user's current parameters of a 100 ml vbti over 46 hours.The infusion was unable to successfully complete as it began to alarm "system error" immediately.The infusion was attempted to be ran using an hs-008 set with lot # 2304023 and expiration date 03/17/2026.Upon further evaluation the pump was opened up and the downstream occlusion cable was completely unplugged, which further confirms the root cause that was highlighted in the sub code.The cable being disconnected caused the pump to alarm "system error" as reported by the end user.It was also noted however that the label with the pump model information is beginning to become erased, making it difficult to identify the pump's information.The lcd screen was also found to have a dark spot on it, which is visible when the pump is both on and off.Functional testing did confirm the reported condition and was duplicated during testing.Reported issue found, device does not meet specification.Three capas have been opened in order to fully investigate and address the root causes of the reported events.Reference to complaint #(b)(4).
Event or Problem Description
On 04/24/2024, intuvie received a report via email from the customer reporting a "system failure" alert on the pump.The pump was received on 5/3/2024.The pump had a complaint form attached to it, which updated the event date to 3/25/2024, the description of the event states, "when turned on to connect patient it said system failure".There was no patient harm during the reported issue.
Additional Manufacturer Narrative
The pump's dhr in qos was reviewed, as all previous test records were reviewed and all were found to have passed.Manufacturing final testing was completed on (b)(6) 2019 and service testing was completed on (b)(6) 2021.The pump was requested for recertification on (b)(6) 2021 and the recertification was finished on (b)(6) 2022.There are no previous complaints on this device.Complaint evaluation was completed on (b)(6) 2024: the pump was received with software version number 5.8.0 and library configuration "ch cci - v1".The pump was tested with the testing protocol for system error alarm / motor functions.The pump's event log was pulled as part of the investigation and upon review it was noted that there was evidence of two system error alarms in the pump's event log, as reported by the end user.The e02 error code was followed by a sub code, which is used to help identify the problem for the system error.The e02 code was followed by the sub code "08" which points to "bad reading on downstream sensor" as the root cause of the system error a 100 ml infusion was ran on the pump using the end user's current parameters of a 100 ml vbti over 46 hours.The infusion was unable to successfully complete as it began to alarm "system error" immediately.Upon further evaluation the pump was opened up and the downstream occlusion cable was completely unplugged, which further confirms the root cause that was highlighted in the sub code.The cable being disconnected caused the pump to alarm "system error" as reported by the end user.Functional testing did confirm the reported condition and was duplicated during testing.Reported issue found, device does not meet specification.A capa has been opened in order to fully investigate and address the root causes of the reported event.
Event or Problem Description
Infutronix llc received a report on april 24th, 2024 from clearview cancer institute clearview diagnostic imaging that a nimbus pump had a system failure alert.This alarm prevented infusion.There was no patient involvement or adverse event reported.

• 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 ; 5086502008
• MDR Report Key: 19348725
• Report Number: 3011581906-2024-00570
• Device Sequence Number: 7412599
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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 FLEX
• Device Catalogue Number: NIMBUS FLEX
• Device Lot Number: 190924720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/19/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-128-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown