MAUDE Adverse Event Report: INFUTRONIX, LLC HALO AMBULATORY INFUSION PUMP SYSTEM ( ALSO WITH TRADE NAME NIMBUS PAINPRO)

Model Number	NIMBUS PAINPRO
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is still waiting for the arrival of the pump to perform the investigation.
Event or Problem Description
The director of sales and business development of infutronix reported that "i got a call from (b)(6) in the office earlier about a patient from (b)(6) calling to complain her pump was leaking.After speaking with the patient, i discovered the leak reported occurred first at the distal connector where the tubing connects to the catheter.She stated it later began leaking at the filter as well.Her pain wasn't being managed with the pump.Pressing the bolus didn't have an effect either.After speaking to her nurse at (b)(6) medical center the decision was made to stop the therapy and pull the catheter.Her husband removed the catheter which was apparently still seated several cm beneath her skin so it doesn't sound like the catheter became dislodged and caused a leak." the patient involved was not injured or harmed.
Additional Manufacturer Narrative
The reported bolus key issue was not confirmed.The bolus key was tested on (b)(6) 2018 and the demand bolus dose was successfully administered.Through the review of the history log of the device, it was confirmed that the bolus key was pressed multiple times during the lockout period, which the bolus feature was deactivated and no bolus could be delivered.
Event or Problem Description
This is a second follow-up for the initially filed mdr 3011581906-2017-00001.

• Brand Name: HALO AMBULATORY INFUSION PUMP SYSTEM ( ALSO WITH TRADE NAME NIMBUS PAINPRO)
• Common Device Name: AMBULATORY INFUSION PUMP
• Manufacturer (Section D): INFUTRONIX, LLC; 177 pine street; natick MA 01760
• MDR Report Key: 6247883
• Report Number: 3011581906-2017-00001
• Device Sequence Number: 673403
• Product Code: FRN
• UDI-Device Identifier: 00814371020044
• UDI-Public: 00814371020044
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2017

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: No Information
• Device Model Number: NIMBUS PAINPRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 01/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1