MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA PATIENT THERAPY CONTROLLER; INFUSION PUMP PROGRAMMER

Model Number	12860
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrected per request of fda, dated (b)(6) 2020.Internal complaint number: (b)(4).
Event or Problem Description
It was reported that the patient therapy controller was reconfigured during an appointment.After the reconfiguration was complete, the ptc was removed from the charger.The ptc then displayed a message indicating that the device must be configured before use.Troubleshooting was performed and the issue was resolved.There were no patient effects reported, and the device will not be returned.

• Brand Name: PROMETRA PATIENT THERAPY CONTROLLER
• Common Device Name: INFUSION PUMP PROGRAMMER
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• MDR Report Key: 6003165
• Report Number: 3006803715-2016-00144
• Device Sequence Number: 14087295
• Product Code: LKK
• UDI-Device Identifier: 00810335020174
• UDI-Public: (01)00810335020174(11)160525
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2016

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: Other
• Device Model Number: 12860
• Device Catalogue Number: 12860
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2016
• Initial Report FDA Received Date: 10/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1