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

Model Number 16827

Device Problem Pumping Stopped (1503)

Patient Problem Discomfort (2330)

Event Date 02/09/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A patient contacted technical solutions to report that their patient therapy controller was showing error code 15.The patient alleged that they were beginning to experience withdrawal symptoms.The patient visited their physician the next morning in order to have their pump inquired.Upon inquiry, a representative from the physician's office reported that the patient's pump was showing error codes 100 and 104.The physician decided to immediately replace the pump.

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-conformances, issues or capas associated with pump function.Additional physical investigation was performed on the device, but the reported issue could not confirmed or denied.Visual inspection of the exterior of the pump did not show any anomalies.An attempt to inquire the pump failed.No tone was heard during the inquiry.An attempt to read the pump memory with the programmer terminal tool, failed.As the pump was unresponsive and could not be inquired, the memory could not be read and the presence of error codes 100 and 104 could not be confirmed or denied.Testing of the battery confirmed it only had 0.99 v, not enough to power and run the module.Neither error code 100 or 104 are attributed to low battery, and furthermore, error codes are not known to cause the battery to drain quickly.The root cause for the loss of battery power 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
• 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: 13715432
• MDR Text Key: 287429458
• Report Number: 3010079947-2022-00039
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Sex: Female