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

Model Number 13827

Device Problem Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2022

Event Type  malfunction  

Event Description

Physician contacted technical solutions to report error codes 100 and 123 showing up on a patient's inquiry report.The physician reported that the patient noticed an error code 11 on their patient therapy controller.When the patient came in to have their pump inquired the next day, the inquiry report showed error codes 100 and 123.Technical solutions instructed the physician to perform an emergency pump stop, followed by a demand bolus of 0mg over one minute to reset the pump.When the pump was reinquired after these steps, no error codes were listed.The physician stated that the patient had not experienced any recent falls, accidents, or mris.The patient was not experiencing any symptoms.

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.Several attempts were made to follow-up with the physician's office to get additional information about this issue, but these attempts were unsuccessful.As physical investigation was not performed on the device, a definitive root cause could not be determined for the alleged issue.If additional information becomes available, a supplemental mdr will be sent.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: 15605901
• MDR Text Key: 306556934
• Report Number: 3010079947-2022-00177
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)190804(10)25071
• 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
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2019
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 25071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• 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 Sex: Male