MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA II PROGRAMMABLE PUMP; IMPLANTABLE INFUSION PUMP

Model Number	13827
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Nausea (1970); Dizziness (2194); Patient Problem/Medical Problem (2688)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint number: (b)(4).
Event or Problem Description
It was reported that a prometra pump that had a volume discrepancy - overinfusion.Patient experienced nauseous and dizzy.Pump was inquired and check for errors.There were no errors or issues observed on the inquiry.The pump was subsequently explanted.
Event or Problem Description
During the follow-up it was informed that the patient was implanted with a new flowonix pump and patient's symptoms have resolved.They are not experiencing any issues with new pump.Patient's pain is managed with the new pump.
Additional Manufacturer Narrative
Internal complaint number: complaint- (b)(4).
Additional Manufacturer Narrative
A review of the device history record, which includes verification of all steps in the manufacturing of the pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging for subject pump was performed.The review did not identify any non-conformances, issues or capas associated with pump function.Device was returned for additional evaluation and investigation.Additional physical investigation was performed on the device, but the alleged issue was not confirmed.Functional analysis of the pump confirmed that the pump successfully primed and flowed within specification as the unit flowed at 93% efficiency.The potential root cause for the alleged volume discrepancy could not be identified.Per the complaint, during the follow-up appointment after the initial volume discrepancy, the reported discrepancy was far less significant.The initial was expected volume: 13 mls, returned volume: 3 mls and the subsequent refill was expected volume: 3.022 mls, returned volume: 2.2 mls.Internal complaint number: (b)(4).

• Brand Name: PROMETRA II PROGRAMMABLE PUMP
• Common Device Name: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• MDR Report Key: 9490998
• Report Number: 3010079947-2019-00175
• Device Sequence Number: 3542064
• Product Code: LKK
• UDI-Device Identifier: 00810335020082
• UDI-Public: 0100810335020082102009017170203
• 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
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2019

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 Expiration Date: 02/03/2017
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 20090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019; 11/21/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 03/16/2020; 08/13/2020
• 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; Required Intervention