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

Model Number	12860
Medical Device Problem Codes	Crack (1135); Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is being evaluated at the manufacturing site.When the investigation is complete, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the touchscreen on the patient therapy controller (ptc) was not functional, and that the screen has a hairline crack.
Additional Manufacturer Narrative
Device evaluation: the device was subjected to visual external and internal inspection, functional testing.The evaluation determined that a component was not operating normally.Based on the results of the investigation, the reported event was confirmed.(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: 6091059
• Report Number: 3006803715-2016-00172
• Device Sequence Number: 16436339
• Product Code: LKK
• UDI-Device Identifier: 00810335020174
• UDI-Public: 010081033502017411160314
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Followup
• Report Date (Section B): 10/12/2016

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: 10/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2016
• Supplement Report FDA Received Date: 11/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1