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

Model Number 13827

Device Problems No Flow (2991); Reset Problem (3019)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the dhr, 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.Internal complaint number: (b)(4).

Event Description

Prometra ii pump.Error codes 100 and 115.Resolved.It was reported that a prometra ii pump had error codes 100 and 115.The patient did report that they did have some "stomach issues" and felt as though the pump was not working prior to reporting for the mri.It was reported that the hard reset will be programmed on (b)(6) 2019 at 10 am.On (b)(6) 2019 at 11.36 it was reported that the hard reset was successful and resolved.F.

• 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 Contact: karen matis ; 500 international drive; suite 200; mount olive, NJ 07828 ; 9734269229
• MDR Report Key: 9496545
• MDR Text Key: 185915033
• Report Number: 3010079947-2019-00177
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2019
• 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 Outcome(s): Other