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

Model Number	12860
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2016
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 the patient therapy controller (ptc) was inconsistent in bolus delivery.
Additional Manufacturer Narrative
Device evaluation: the patient therapy controller (ptc) was subjected to external and internal visual inspection, as well as, functional testing.The ptc operated per specification.An error code indicating that the ptc could not locate and communicate with the pump was observed in the error log.Based on the results of the investigation, the reported issue could not be confirmed when the device was used in accordance with the instructions for use (ifu).(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: 6125414
• Report Number: 3006803715-2016-00188
• Device Sequence Number: 19028505
• Product Code: LKK
• UDI-Device Identifier: 00810335020174
• UDI-Public: 010081033502017411160318
• 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): 10/28/2016

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: 11/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/23/2016
• Supplement Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1