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	No Consequences Or Impact To Patient (2199)
Date of Event	12/31/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the returned pump programmer was subjected to external visual examinations and functional testing.The evaluation determined that the display issue was due to a software timing problem.Based on the investigation, the reported event was confirmed.(b)(4).
Event or Problem Description
It was reported that the programmer printouts displayed incorrect information.There were no patient effects reported and the device was returned for evaluation.
Additional Manufacturer Narrative
The manufacture date was corrected in this supplemental report.(b)(4).

• 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: 5509612
• Report Number: 3006803715-2016-00046
• Device Sequence Number: 1162298
• Product Code: LKK
• UDI-Device Identifier: 00810335020167
• UDI-Public: 010081033502016711150730
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/04/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2016
• Supplement Report FDA Received Date: 09/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1