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 Codes	Vomiting (2144); Patient Problem/Medical Problem (2688)
Date of Event	09/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
A health care professional reported that the patient was vomiting and experiencing "typical withdrawal symptoms".On the patient's way to the hospital, patient attempted to deliver a bolus due to the symptoms she was experiencing using the patient therapy controller but received an error code.Patient was advised to call their pain management facility to troubleshoot the issue.Patient was subsequently admitted to the hospital.A company representative was sent to the hospital to inquire the pump.During initial inquiry of the pump with a programmer, the programmer displayed error codes.Troubleshooting was performed and successfully cleared the error codes displayed on the programmer and ptc.After troubleshooting, patient successfully delivered a bolus without issue.
Additional Manufacturer Narrative
It was originally reported that the patient was hospitalized due to the reported withdrawal symptoms.Additional information was later received and it was determined that the patient was never hospitalized due to the reported issue.(b)(4).
Event or Problem Description
A health care professional reported that the patient was not admitted to the hospital.The patient had only visited the emergency room and was later released.No additional issues were reported.

• 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: 6949858
• Report Number: 3010079947-2017-00145
• Device Sequence Number: 18959127
• Product Code: LKK
• UDI-Device Identifier: 00810335020174
• UDI-Public: 010081033502017411170516
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization