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

Model Number NIMBUS II PLUS

Device Problems Infusion or Flow Problem (2964); Pumping Problem (3016)

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

Event Date 12/19/2023

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 except the complaint which prompted the filing of this mdr.Device return requested for evaluation.

Event Description

On (b)(6) 2023, infutronix received a report that a pump had a flow rate issue, causing loss of infusion parameters.The infusion cannot resume without causing delay in treatment.Requested device to be returned.

Event Description

"we had a pt that had more infusion time left than what was calculated.Apparently, it was alarming and he tried to fix it himself, he denied shutting off or seeing it off.Here is the note below."pt called office about volume of chemo remaining to infuse.Pt states there are 15mls remaining.Pt reports pump alarmed on monday evening and yesterday evening.Pt states he did not call the support line reps but just manipulated the bag and iv line himself until it stopped alarming.Pt state the pump must have stopped at some point and time because he was scheduled to come for pump dc at 1145.Current volume would be completed around 1830 to 1900.Discussed with jen mcmanus np, new order to have pt come today in at 1630 to have pump d/ced, with approx 4ml remaining in bag." pump number is 704250.".

Manufacturer Narrative

Dhr was reviewed, and the pump passed all previous tests.There is one previous complaint for an abrupt power off.The pump was received on 1/12/2024.The pump was evaluated on 1/23/2024.The results are below: the pump was tested with the infusion flow rate accuracy test from document # it-004-wi-003: equipment used: infusion set: model: hs-008 lot number: 2305022 scale: model: fx500i serial number:(b)(6) calibration date: 03/30/2023 next calibration due date: 03/31/2024 the pump ran an 100 ml infusion, which measured to be only 97.86 ml actually infused.This makes the flow rate accuracy -2.14%, which is within the passing criteria of +/-5%.Reported issue is not confirmed.Device performing to specification.Pump will be pushed to capa for further investigation underneath capa # it2022-06.

• 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: 18474822
• MDR Text Key: 332434809
• Report Number: 3011581906-2023-00787
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NIMBUS II PLUS
• Device Catalogue Number: NIMBUS II PLUS
• Device Lot Number: 210303180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2021
• 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
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 91 KG