MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC PROMETRA PUMP PROGRAMMER; INFUSION PUMP PROGRAMMER

Model Number	12828
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint number: (b)(4).
Event or Problem Description
It was reported that the programmer screen incorrectly displayed the pump reservoir volume during an appointment.Troubleshooting was performed, and the issue appeared to have been resolved.It was noted that the patient complained of increased pain after the previous appointment.

• Brand Name: PROMETRA PUMP PROGRAMMER
• Common Device Name: INFUSION PUMP PROGRAMMER
• Manufacturer (Section D): FLOWONIX MEDICAL, INC; 500 international drive; suite 200; mount olive NJ 07828
• MDR Report Key: 5917246
• Report Number: 3006803715-2016-00135
• Device Sequence Number: 13571308
• Product Code: LKK
• UDI-Device Identifier: 00810335020167
• UDI-Public: 010081033502016711150826
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2016

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: Physician
• Device Model Number: 12828
• Device Catalogue Number: 12828
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2016
• Initial Report FDA Received Date: 08/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1