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

Model Number	NIMBUS II FLEX
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint record was reopened for device evaluation.The mdr reportability of the complaint was upgraded to "yes" due to this, the initial complaint code has now been changed to mdr reportable according to protocol 6.Analysis of the returned device was completed.The pump was tested following battery & power complaint investigation protocols.The event log was reviewed, and there was a line that indicates an abrupt power off took place.Line 0 has a log_event_on without a log_event_off before it.It took place before the infusion infused any medication during an 86 ml infusion.During functional testing, the reported problem was duplicated.A new 86 ml infusion abruptly powered off once it started without any alert or alarm.A new battery was then put into the pump, battery reset was completed, and a new 100 ml infusion ran until completion without another abrupt power off taking place.The root cause for the failure is a depleted battery.The complaint was reviewed, evaluated, and determined to be included in capa.
Event or Problem Description
On 1-7-2021 e.Caisse of zyno solutions received an email from l.Troppmann of 678-fairbanks, troppmann stated that pump (b)(6) would power off even after a battery change.Did not happen during an infusion.No patient involved.

• Brand Name: NIMBUS II FLEX AMBULATORY INFUSION PUMP
• Common Device Name: NIMBUS II FLEX 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: 19169586
• Report Number: 3011581906-2024-00283
• Device Sequence Number: 7349453
• Product Code: FRN
• UDI-Device Identifier: 00817170020093
• UDI-Public: 00817170020093
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: KD153193
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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 II FLEX
• Device Lot Number: 190527480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown