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

Model Number	12860
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Patient Problem/Medical Problem (2688)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint number: (b)(4).
Event or Problem Description
It was reported that the patient had multiple error code 38s and potential over delivery of medication.Patient reports withdrawal symptoms - sweating, nausea and vomiting.
Additional Manufacturer Narrative
Device was returned for additional evaluation and investigation.A review of the device history record, which includes verification of all steps in the manufacturing of the patient therapy controller, verification of all final testing performed by/on the patient therapy controller, and packaging for subject patient therapy controller was performed.The review did not identify any non-conformances, issues or capas associated with patient therapy controller function.Functional testing confirmed that the patient therapy controller was able to power on using the power button.The wall charger was plugged in and an attempt to connect to the clinician programmer was successfully achieved.After connecting to the clinician programmer, the patient therapy controller was able to accept a new prescription and deliver a bolus without issue.Attempts by engineering to replicate the issue were unsuccessful.Error logs were reviewed and 279 error code 38s were discovered from 8/21/2019 through 9/23/2019.Only 11 error code 38s were followed by an error code 41 "pump is in bolus mode." if an interruption occurs after pump programming has completed but before the patient therapy controller receives final confirmation from the pump, the patient therapy controller will report a failure even if the pump was successfully programmed.The failure manifests as error code 38.The twenty-four hour window and lockout period timers are not updated.As a result of this shortcoming in design, a patient can manipulate the number of boluses allowed by consistently breaking the communication between the patient therapy controller and the pump.It is very likely this is the cause for the volume discrepancy due to the large number of error code 38s observed.Please note that the patient's pump was explanted, this explant was captured through mfr 3010079947-2019-00131.Internal complaint number: complaint-(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: 9433081
• Report Number: 3010079947-2019-00164
• Device Sequence Number: 10867932
• Product Code: LKK
• UDI-Device Identifier: 00810335020174
• UDI-Public: 010081033502017411190108
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: Health Professional
• Device Model Number: 12860
• Device Catalogue Number: 12860
• Device Lot Number: F01081908
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 09/29/2020
• 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: Other