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

Model Number 13827

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 01/25/2022

Event Type  Injury  

Event Description

Information was received alleging a pump explant to be performed due to an infection.Initially, the patient was seen at the physician's office and a drainage from their incision was noted.The patient also reported having a burning sensation at the incisional site.No redness or edema was noted at this time, and the incision was cleaned.A week later, the patient was seen at the physician's office again, where they informed that they went to the er the day before.The also had a fever and pus was draining from the incision site.The patient was prescribed antibiotics and other medication for the fever.No infection or pus was noted at this appointment.A week later, the patient was seen at the office and had a pus-like drainage from the incision site.The patient's pump was turned off and is being treated with oral medication.

Manufacturer Narrative

Pending additional follow up information.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.Per the instructions for use of the device, pump pocket infection is a known possible risk of use of the device.Internal complaint number: (b)(4).

Event Description

Additional information confirmed that the patient's pump pocket was infected.Reporter stated that the physician did not know what caused the infection.The pump was later explanted.

Manufacturer Narrative

Device was explanted and was not returned.Reporter stated that the cause of the infection was unknown.Internal complaint number: (b)(4).

• Brand Name: PROMETRA II PROGRAMMABLE PUMP
• Type of Device: 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: 13612910
• MDR Text Key: 286441964
• Report Number: 3010079947-2022-00030
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)220722(10)28074
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2022
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 28074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female