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

Model Number NIMBUS II PLUS

Device Problems Device Alarm System (1012); Mechanical Problem (1384); Failure to Deliver (2338); Device Sensing Problem (2917); Complete Loss of Power (4015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2024

Event Type  malfunction  

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.Device was returned on 03/05/2024.Several capas had been opened in order to fully investigate and address the root causes of the reported event.Analysis of the returned device was completed on 3/25/2024.The results are below: the pump's event log was pulled and reviewed, in order to identify the unknown reported condition by the end user.Upon review, several different alarms and problems were found throughout the event log.From this section below there is evidence of upstream alarms as shown by the "e04" code, downstream occlusion as shown by the "e05" code", and system error alarms as shown by the "e02" code.See event log of the complaint in question for detail.The system error code in event line 29 was followed by sub code 08 which means "bad reading on downstream sensor".The system error alarm code was found 14 times throughout the pump's log.The upstream occlusion alarm was found 7 times in the log and the downstream occlusion was found 14 times throughout the log.Also found during the pump's event log review were several abrupt power offs.An abrupt power off can be seen below on event line 563 by the "log_event_on" code without an "log_event_off" code before it: seeing the code "log_event_on" code without an "log_event_off" code before it points to the abrupt power off as it means that the pump had to be powered on without being powered off prior, meaning that it turned off on it's own.Upon undergoing functional testing, the pump's event log was found to undergo several alarms including system error and abrupt power offs which are both reportable conditions.The reportability of the complaint has since been upgraded.All other tests successfully passed, with all alarms occurring as desired and no further problems diagnosed.Reported issue found, device not performing to specification.

Event Description

On (b)(6) 2024, infutronix received a report that a pump had an unknown issue from customer.The infusion cannot resume without causing delay in treatment.No patient harmed.Device was returned on 03/05/2024.Detail of the evaluation of this pump is in section h of this mdr.

• Brand Name: NIMBUS II PLUS AMBULATORY INFUSION PUMP
• Type of Device: 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: 19009282
• MDR Text Key: 339010303
• Report Number: 3011581906-2024-00479
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00817170020161
• UDI-Public: 00817170020161
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NIMBUS II PLUS
• Device Catalogue Number: NIMBUS II PLUS
• Device Lot Number: 2206213120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1