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.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 5/13/24 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: (b)(6) reviewed manufacture final test record from (b)(6) 2020 (b)(6) reviewed manufacture final test record from (b)(6) 2020 (b)(6) reviewed manufacture final test record from (b)(6) 2020 (b)(6) reviewed manufacture final test record from (b)(6) 2020 (b)(6) reviewed manufacture final test record from (b)(6) 2020 (b)(6) reviewed manufacture final test record from (b)(6) 2020 (b)(6) reviewed manufacture final test record from (b)(6) 2020 (b)(6) reviewed manufacture final test record from (b)(6) 2020 (b)(6) reviewed manufacture final test record from (b)(6) 2020 (b)(6) reviewed manufacture final test record from (b)(6) 2020 (b)(6) reviewed manufacture final test record from (b)(6) 2020 (b)(6) reviewed manufacture final test record from (b)(6) 2020 (b)(6) reviewed manufacture final test record from (b)(6) 2020.The pump serial numbers which were provided by the end user allow the possibility to review overall.It was discovered that all (b)(4) 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(b)(4) 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 (b)(6) 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 (b)(4) case.Complaint numbers (b)(4) will be representing the plurality of the non-reportable "upstream occlusion" devices mentioned in sf case (b)(4) 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: compaint # (b)(4).
Additional Manufacturer Narrative
This complaint is being reopened for device evaluation as the pump has been returned.There are no other complaints on this device.The reported issue was confirmed through complaint investigation and this device does not need further individual investigation as the product has been removed from the market.This capa pertains to battery/power complaints on the nimbus ii devices and can be referenced to get a full scope of the investigation that was completed on this failure type.The historical test records were reviewed, and not the entirety of the dhr.There was no clinical or impact health effects associated with this report.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 01760 ; 5086502007
• MDR Report Key: 19392392
• Report Number: 3011581906-2024-00599
• Device Sequence Number: 7799455
• 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): 06/27/2024

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: 06/13/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/27/2024
• 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