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

Model Number 13827

Device Problems Failure to Infuse (2340); Unexpected Shutdown (4019)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

Pending completion of device analysis.(b)(4).

Event Description

Sales representative contacted technical solutions to report a prometra ii 20 ml pump with error codes 100 and 104.Patient was originally brought in to see their managing physician due to lack of pain relief and an error code 11 on their patient therapy controller.After inquiring the pump, error codes 100 and 104 were observed.A little over a week later, the pump was explanted and replaced due to the pump displaying error codes 100, 101, 104 and 105.

Manufacturer Narrative

Additional information: g1 (second address).Corrected information: h3, h6 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-conformances, issues or capas associated with pump function.Additional physical investigation was performed on the device, confirming the alleged issue.Analysis of the pump's functionality was performed.Engineering was unable to inquire the pump.Engineering was unable to perform a memory dump on the pump.The error code 100/104 indicated in the complaint was due to an unloaded battery voltage below the battery replace indicator of 2.4v.The top cover was removed from the pump.A visual inspection of the module compartment found a floating conductive part (inductor l 1).This loose component may have shorted the electronic circuits, and speeded up discharging of the battery and eventually shut off the pump.The root cause for the complaint has been determined to be due to the broken component on the module breaking off and causing a short.The cause for the component coming off the module could not be determined.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
• MDR Report Key: 10540332
• MDR Text Key: 207131653
• Report Number: 3010079947-2020-00294
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(10)24304(17)181024
• Combination Product (y/n): N
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2018
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 24304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention