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

Model Number	NIMBUS II PLUS
Medical Device Problem Codes	Power Problem (3010); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/08/2024, infutronix received a report that a pump had power issue - device powers self off.The complaint will be 14 of 14 for immediate power off event.No patient was involved.Device was requested to be returned.
Additional Manufacturer Narrative
Although the reported issues haven't been tied to any particular serial number, 13 out of 14 customer's reported devices with potential issues were provided in gfe response from end user (b)(6) on (b)(6) 2024 which belong to the same lot#.All devices will be reviewed as a generalization.This complaint record is currently not tied to a single pump serial number.When the pump device has been returned, the records will be updated to identify which devices are reportable/non-reportable and to identify which pump sn belongs to which complaint record.The serial numbers which were provided by the end user allow the possibility for historical test record review overall.The historical test records in qos were reviewed and all previous test records were found to have passed, with manufacturing final testing being completed on 04/28/2020.Below lists the sns and test records reviewed: 701379 reviewed manufacture final test record from 4/28/2020 701273 reviewed manufacture final test record from 4/28/2020 701272 reviewed manufacture final test record from 4/28/2020 701378 reviewed manufacture final test record from 4/28/2020 701376 reviewed manufacture final test record from 4/28/2020 701281 reviewed manufacture final test record from 4/28/2020 701278 reviewed manufacture final test record from 4/28/2020 701380 reviewed manufacture final test record from 4/28/2020 701277 reviewed manufacture final test record from 4/28/2020 701377 reviewed manufacture final test record from 4/28/2020 701279 reviewed manufacture final test record from 4/28/2020 701276 reviewed manufacture final test record from 4/28/2020 701280 reviewed manufacture final test record from 4/28/2020 the pump serial numbers which were provided by the end user allow the possibility to review overall.It was discovered that all 13 pumps fall under the same lot #.The devices were manufactured on 04/17/2020 and is included in lot # 200417282 which was a batch of 282 pumps was received initially from manufacturing on 05/08/2020 and approved on 05/14/2020.The pump devices were configured to the customer's library and shipped to the customer quadmed/dorchester county emergency medical services on 08/21/2020.There are no previous complaints on any of the pump devices.Complaints (b)(4) will represent the plurality of the "power off" reportable devices mentioned in this sf 65100 case.Complaint numbers (b)(4) will be representing the plurality of the non-reportable "upstream occlusion" devices mentioned in sf case 65100 and will be updated to become reportable if additional information becomes available.This complaint record and other associated opened records will be reopened in the event any of the product(s) is/are involved or additional information becomes available.A capa has been opened in order to fully investigate and address the root cause of the reported event.Mdr follow-up will be filed and updated in the event the device involved or additional information becomes available.[reference: complaint # (b)(4)].
Additional Manufacturer Narrative
This complaint is being reopened for device evaluation as the pump has been returned.There is a previous complaint #(b)(4) on this device.A physical inspection was completed and upon further evaluation there was no damage found at all to the pump.There was also one label on the side of the pump that was placed there by the end user.The pump's event log was pulled as part of the evaluation and upon review it was noted that there was an abrupt power off found in the log, as reported by the end user.An abrupt power off can be seen on event line 374 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 its own.The pump was tested with the following testing protocol for battery and power complaints.It is noted that the pump was received without a battery in the pump, as the one used by the end user was not returned.A new battery was put into the pump to complete the test.A 100 ml infusion was run on the pump using the end user's parameters of a rate of 12 ml per hour.The infusion was successfully completed and the pump did not power off abruptly before finishing.The infusion was run using an hs-008 iv cassette with lot # 2301005 and expiration date (b)(6) 2026.Functional testing did confirm the reported condition, device does not meet specification.The reported issue was confirmed through complaint evaluation and this device does not need further individual investigation as the product has been removed from the market, and all capas pertaining to the product have been completed and closed.This complaint has been reviewed, evaluated, and determined to be a part of capa.Reference complaint # (b)(4).

• Brand Name: NIMBUS II PLUS 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
• MDR Report Key: 19393662
• Report Number: 3011581906-2024-00575
• Device Sequence Number: 7762048
• Product Code: FRN
• UDI-Device Identifier: 00817170020161
• UDI-Public: 00817170020161
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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 PLUS
• Device Catalogue Number: NIMBUS II PLUS
• Device Lot Number: 200417282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2020
• 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 Sex: Unknown