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

Model Number 13827

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Discomfort (2330); Inadequate Pain Relief (2388)

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

Pending completion of device analysis and review of device history record.Internal complaint number: (b)(4).

Event Description

Agent contacted technical solutions to report a pump explant due to multiple under infusion volume discrepancies.At a refill appointment, the first under infusion was observed with the expected volume being 3.8ml and the actual aspirated volume being 9ml.Months later, a second volume discrepancy was observed with the expected volume being 4ml and the actual aspirated volume being 9ml.Approximately a week later, a catheter dye study was performed and confirmed that the catheter was found to be patent.The day following the dye study, the patient alleged an increase in pain and withdrawal symptoms.The pump was later explanted.On the day of the explant, a final volume discrepancy was observed, with the expected volume being 2.6ml and the actual aspirated volume being 8ml.

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 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-conformance's, issues or capas associated with pump function.Additional physical investigation was performed on the device, confirming the alleged issue.Visual inspection of the pump did not find any exterior anomalies.Engineering was unable to flush the catheter access port (cap), which would lead to a volume discrepancy, confirming the complaint.The cap and suture ring were removed, and a second decontamination was done.Functional analysis of the pump confirmed the pump successfully primed and flowed within design specifications without the cap.During the second decontamination the cause for the occlusion was lost.The root cause for this issue is occlusion in the cap.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: 14160157
• MDR Text Key: 289616665
• Report Number: 3010079947-2022-00072
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)211022(10)27079
• 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: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2021
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 27078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2020
• 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
• Patient Sex: Female