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

Model Number NIMBUS II PLUS

Device Problems Backflow (1064); No Flow (2991)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/24/2023

Event Type  malfunction  

Manufacturer Narrative

Return of the device has been requested.As of the date of this report, device has not been returned.

Event Description

Patient reported that two days after total knee replacement surgery, the device fell on the floor."it showed a 000 reading and we weren't sure if it was still working.A nurse reset the device and said it was working.That day, i'm not sure when, i felt like fluid was only entering the tissue on my outer thigh rather than going to the back of my knee, i felt cold fluid enter." "both catheters had blood in them"."the bandage showed evidence of blood leaking down onto the bandage." the next day, a nurse visited, and "agreed there was some leakage and blood in the catheters.[nurse] offered to remove the catheters".Patient refused to have the catheters removed due to being in pain.Patient indicated that just after the nurse left, they "stood up and a lot of liquid ran down [their] leg from the metal catheter leading to the front of the knee".Patient "didn't want to get the dressing wet".The nurse was called again, and the catheters were removed.Patient indicated "medication was not being pushed through the catheters sufficiently to prevent back flow".Patient also observed "pinkish bubble in the line leading from the pump going to the catheter for the back of the knee.The machine whirred about every hour, but the bubble did not move." at the time the catheters were removed, patient observed: "the drip bag for the back of the knee was dispensed with 1000 ml and it looks to me like about half of that was gone.The other bag, for the front of the knee, was prescribed for 500 ml and it looks unused." "i did not receive the prescribed medication and consequent pain relief"."i suffered unnecessarily because the pumps did not work properly".Pump was in use for 2.5 days before the catheters were disconnected.There was no obvious physical damage to the pump.No kinks, occlusions or visible defects in the tubing or reservoir.There was no backup device available to continue infusion.Medication being infused was bupivacaine.

Manufacturer Narrative

A review of the device history record has been completed.This pump passed all previous tests.Complaint data was reviewed, there are no previous complaints on this device.Analysis of the returned device is complete.The results are below: the pump was connected to an administration set (hs-008, lot # 2203016) and a 100 ml infusion was ran on the pump.The pump was observed while it ran, and it was infusing the correct direction, and not backwards.The volume infused was 96.31 ml.The programmed volume was 100 ml.So, the flow rate deviation is -3.69%.The flow rate accuracy is within +/- 5%, which meets the passing criteria.

• 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: chaoyoung lee ; 177 pine street; natick, MA 01760 ; 5086502008
• MDR Report Key: 16852157
• MDR Text Key: 314749511
• Report Number: 3011581906-2023-00056
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00817170020086
• UDI-Public: 00817170020086
• 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: Other,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• 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 Lot Number: 1809201152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2017
• 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: 67 YR
• Patient Sex: Female