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

Model Number	13827
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	Nausea (1970); Inadequate Pain Relief (2388)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Additional 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 additional investigation was not performed on the device, a definitive root cause could not be determined for the alleged issue.A supplemental mdr will be performed if/when additional information becomes available.Internal complaint number: (b)(4).
Event or Problem Description
Reporter contacted technical solutions to report that a patient's pump was unable to communicate with their clinician programmer.The reporter stated that the programmer did not emit any beeping and does not recognize the pump when held directly over it.The reporter tried restarting the programmer several times and changing the batteries, but both of these steps were unsuccessful in resolving the issue.The reporter stated that the pump is very superficial on this patient, and they could feel the refill septum, confirming that the pump was not flipped.The reporter's programmer was able to successfully inquire about six patients the previous day, and the patient did not have a patient therapy controller to test whether that device was able to connect with the pump or not.The patient reported an increase in pain over the previous four to five days.The patient also reported nausea, but stated that this could be contributed to the new medication that they had started recently.The patient had no recent mris, but did reportedly have a fall around three days prior.Technical solutions advised the reporter that they should attempt connecting to the pump with a different programmer.The reporter later communicated that they located another clinician programmer to perform another inquiry, but the inquiry was unsuccessful.Technical solutions consulted with flowonix's director of clinical engineering and subsequently relayed to the reporter that the patient's pump would need to be explanted.Technical solutions requested that the reporter update technical solutions when the pump replacement was scheduled.

• Brand Name: PROMETRA II PROGRAMMABLE PUMP
• Common Device Name: 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: 16775968
• Report Number: 3010079947-2023-00033
• Device Sequence Number: 6868194
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)180723(10)23974
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2018
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 23974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male