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

Model Number	12860
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2016
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.Internal complaint number: (b)(4).
Event or Problem Description
It was reported that the patient therapy controller (ptc) displayed battery charging and bolus delivery issues.There were no patient effects reported, and the device was returned for evaluation.
Additional Manufacturer Narrative
Device evaluation: the device was subjected to external visual inspection and simulated use testing for bolus delivery and charging, and the ptc error log history was reviewed.Multiple error codes were observed around the time the complaint was reported.Based on the results of the investigation, no definitive cause can be determined for the reported bolus delivery issue with the information provided.The reported battery charging issue could not be confirmed as the unit was able to charge and held charge for several weeks.(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: 6142603
• Report Number: 3006803715-2016-00193
• Device Sequence Number: 1129276
• Product Code: LKK
• UDI-Device Identifier: 00810335020174
• UDI-Public: 010081033502017411160725
• 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): 11/04/2016

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: 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: 11/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2016
• 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