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

Model Number 16827

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Dizziness (2194); Movement Disorder (4412); Speech Disorder (4415)

Event Date 06/30/2021

Event Type  Injury  

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 remains implanted and was not returned for additional evaluation and investigation.As there was no additional investigation performed on the device and no additional information available, a definitive root cause could not be determined for the alleged issue.A supplemental mdr will be sent if new information is received.Internal complaint number: (b)(4).

Event Description

Clinical specialist (cs) contacted technical solutions to report patient effects following an mri.At the mri appointment when the pump was emptied a 2.8ml overinfusion volume discrepancy was observed.The pump was emptied and turned off before the mri.The patient was scanned for approximately an hour, and felt lightheaded when exiting the scan.Cs performed the post-mri procedure and pulls a 30 second vacuum using a 5cc syringe to ensure the valves are closed.The pump was then refilled and restarted.Cs reported that the patient was brought to the hospital a few hours later due to slurred speech and difficulty walking.It was confirmed that the patient did not take any oral medication before or after the mri.The patient was administered narcan while in the emergency room.A volume check was done while the patient was in the hospital and there was no discrepancy observed.No additional information was available.

• 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: 12247807
• MDR Text Key: 264142545
• Report Number: 3010079947-2021-00216
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020242
• UDI-Public: (01)00810335020242(10)26548(17)201223
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2020
• Device Model Number: 16827
• Device Catalogue Number: 16827
• Device Lot Number: 26548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2020
• 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): Hospitalization; Other