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

Model Number	13827
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
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, and packaging for subject pump was performed.The review did not identify any non-conformances, issues or capas associated with pump function.Device was discarded and not returned for additional evaluation and investigation.As additional investigation was not performed on the device, a definitive root cause could not be determined for the alleged issue.Internal complaint number: (b)(4).
Event or Problem Description
Patient tracking received a tracking form through email reporting a pump replacement surgery.The reason for surgery was reported to be, "no aspiration; pump would not flow." the device was discarded after surgery.Additional communication with the agent covering the issue confirmed that a cap study was performed, during which the lack of aspiration and flow was observed.The patient had reported a loss of therapy.The agent also reported that an under infusion volume discrepancy was observed, although no additional information was available about this discrepancy.When the physician removed the catheter from the patient's pump during surgery, the metal pump stem reportedly dislodged from the outer silicone stem.

• 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
• Manufacturer (Section G): FLOWONIX MEDICAL, INC.; 120 forbes blvd; suite 170; mansfield MA 02048
• Manufacturer Contact: james bennett ; 500 international drive; suite 200; mount olive, NJ 07828 ; 9734269229
• MDR Report Key: 16984682
• Report Number: 3010079947-2023-00046
• Device Sequence Number: 6762501
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)180815(10)24052
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2023

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: 08/15/2018
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 24052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male