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

Model Number	12860
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the buttons on the patient therapy controller (ptc) were damaged.The device was unresponsive when charged or when a button was pushed.The patient reported that there was no physical damage.The patient reported that she experienced a decrease in pain relief.The managing infusion nurse later reported that the button issue did not appear to be due to wear and tear due to normal usage, and that it is possible the device was damaged in some way.
Additional Manufacturer Narrative
Device evaluation: the device was subjected to external and internal visual examinations, as well as, functional testing.The investigation confirmed that the buttons were damaged and that the device could not be powered on.Internal complaint number: (b)(4).

• 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: 6039656
• Report Number: 3006803715-2016-00160
• Device Sequence Number: 19039203
• Product Code: LKK
• UDI-Device Identifier: 00810335020174
• UDI-Public: 010081033502017411160314
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2016

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: Lay User/Patient
• Device Model Number: 12860
• Device Catalogue Number: 12860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2016
• Supplement Report FDA Received Date: 12/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1