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

Model Number	NIMBUS II FLEX
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964); Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device is not yet returned to the distributor.
Event or Problem Description
A distributor reported to infutronix on (b)(6) 2018 about a flow rate accuracy issue and a system error issue.The distributor forwarded information received from the user facility on 10/11/2018: "a patient who was connected to a new pump on tuesday returned today for de-access and reported that her pump had shut off 8 times during the infusion with the screen stating 'system error'.She said she spoke by phone several times to a 'nurse from the company' and restarted the pump each time.Today, the screen showed that the infusion was complete at the appropriate time, but there was more than the usual amount of overfill fluid remaining in the bag.The distributor is still waiting for response about patient injury." on (b)(6) 2018 the distributor obtained more information from the user facility.The user facility confirmed that there was no patient injury.The device serial number remained unknown.The programmed volume was 250ml and programmed time was 46 hours.The medication being infused was fluorouracil.The administration set used at the time of the event was discarded and would not be returned for evaluation.No other patient information was available.
Additional Manufacturer Narrative
The distributor provided additional information on the affected device to infutronix on (b)(6) 2018.The serial number was confirmed then to be (b)(4) and the model type was corrected as nimbus ii flex.The reported under-infusion issue could not be confirmed and the reported system error issue was confirmed.The device was evaluated for these issues on (b)(6) 2018.The root cause of the system error issue could not be established.The under-infusion issue could not be confirmed because the device alarmed "system error" during the testing.The affected device has been taken out of service.
Event or Problem Description
This is the follow up report for the initially submitted mdr (3011581906-2018-00022).

• Brand Name: NIMBUS FLEX
• Common Device Name: AMBULATORY INFUSION PUMP
• Manufacturer (Section D): INFUTRONIX, LLC; 177 pine street; natick MA 01760
• MDR Report Key: 7977995
• Report Number: 3011581906-2018-00022
• Device Sequence Number: 16442836
• Product Code: FRN
• UDI-Device Identifier: 00817170020000
• UDI-Public: 00817170020000
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K153193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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: 171027-180
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1