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

Model Number	NIMBUS FLEX
Medical Device Problem Codes	Mechanical Problem (1384); Noise, Audible (3273)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has not yet been returned.
Event or Problem Description
Infutronix received a power issue of the device from a user facility representative on (b)(6) 2019 that "i have a pump on my desk that was returned from one of our facilities for the following reasons (their words): when the pump boluses the screen goes blank.It's making a sound that doesn't sound like the others - it's a slow grinding sound.When the cassette is removed the screen says upstream occlusion instead of cassette loading error.The patient's blood sugar was very high then low and it appears to be from the pump not bolusing correctly.The serial # of the pump is (b)(4)." infutronix followed-up with this representative on (b)(6) 2019 and obtained additional information: "medication infused: saline/insulin date event noticed: we pulled the pump out of service in december because it would give a software error message.We tried to use it again a few weeks ago and it had all the other problems.Patient injury: it was being used on a patient.We switched to a different pump and were able to get her blood sugar numbers back down to normal.(no) device operator: our medical technician was operating the pump".No other patient information was provided to infutronix.
Event or Problem Description
This is a follow-up for the initially filed mdr (3011581906-2019-00005).
Additional Manufacturer Narrative
The issue that "when the cassette is removed the screen says upstream occlusion instead of cassette loading error" was confirmed.The device was sent back to the contract manufacturer and evaluated for the reported issue.It was determined that the reported issue was caused by the pump cpu flash rom data loss.- attachment: [evaluation report for complaint-(b)(4).Pdf].

• Brand Name: NIMBUS FLEX
• Common Device Name: AMBULATORY INFUSION PUMP
• Manufacturer (Section D): INFUTRONIX, LLC; 177 pine street; natick MA 01760
• MDR Report Key: 8596084
• Report Number: 3011581906-2019-00005
• Device Sequence Number: 2179971
• Product Code: FRN
• UDI-Device Identifier: 00817170020000
• UDI-Public: 00817170020000
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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 FLEX
• Device Lot Number: A100F-161114700
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1