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

Model Number	12860
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Device Displays Incorrect Message (2591); Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 8/19/2016, the ptc history log was retrieved, which had no saved record of two boluses being delivered within 20 minutes from each other.On 9/1/2016, it was determined that the reported issue was not a reportable event with the information available at the time of the decision.However, additional information was made available on 9/2/2016 which indicated that the issue was reportable.Additional information is not available to confirm the reported lockout issue.The reported lockout issue could not be replicated on a different device under similar conditions.A supplemental report will be filed if additional information become available regarding the reported event.(b)(4).
Event or Problem Description
After a refill appointment on (b)(6) 2016, it was reported that the patient therapy controller (ptc) displayed an error message indicating that a physician must configure the device before use.The device was reconfigured on (b)(6) 2016.During the reconfiguration appointment, an error code was displayed when the patient initially attempted to deliver a bolus with the ptc.The second attempt was successful.When this bolus was being delivered, the ptc incorrectly displayed that the next bolus will be available in 20 minutes, when it should have been 4 hours and 20 minutes.The patient bolused themselves again once the 20 minute period was complete.The ptc then displayed the correct period of 4 hours and 20 minutes for the next bolus.It was later reported that the patient was able to give themselves more bolus than allotted within a 24 hour period.There were no patient effects reported.No further issues were reported, and the device will not be returned.
Additional Manufacturer Narrative
Additional investigation was performed to replicate the reported issue.A review of the ptc error log history was performed, and a timeline was developed to replicate the likely sequence of events.The investigation could not confirm the reported issue.The likely cause of the issue is that a demand bolus was programmed with the clinician programmer, and when a ptc bolus was attempted, the ptc screen displayed the time remaining from the bolus initiated by the clinician programmer.The ptc likely then delivered a bolus after the clinician programmer initiated demand bolus was completed.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: 5990253
• Report Number: 3006803715-2016-00138
• Device Sequence Number: 18852384
• Product Code: LKK
• UDI-Device Identifier: 00810335020174
• UDI-Public: 010081033502017411151019
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/02/2016

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?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2016
• Supplement Report FDA Received Date: 06/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1