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

Model Number	12860
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2016
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 patient therapy controller (ptc) was reconfigured during an appointment.After the reconfiguration was complete, the ptc displayed a message indicating that the device must be configured before use multiple times over a three week period.There were no patient effects reported.
Additional Manufacturer Narrative
Device evaluation: the returned patient therapy controller was subjected to internal and external visual examination, functional and electrical testing.The evaluation determined that the issue was likely due to battery depletion, leading to the device being reset.Corrected g8 per request of fda, dated 10/sep/2020.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: 6142614
• Report Number: 3006803715-2016-00190
• Device Sequence Number: 223920
• Product Code: LKK
• UDI-Device Identifier: 00810335020174
• UDI-Public: 010081033502017411160722
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: 11/01/2016
• Initial Report FDA Received Date: 12/02/2016
• Supplement Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1