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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
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 was not returned for additional evaluation and investigation as the issue was resolved and explant did not occur.A definitive root cause could not be determined for the alleged prior communication issue.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).
Event or Problem Description
Physician contacted technical solutions to report a pump that was unable to communicate with several clinician programmers.Physician stated that the pump is very superficial on the patient and did not appear to have flipped.The patient had not experienced any recent mri's, falls/accidents, or other events that the physician thought could have caused this issue.Physician stated that the patient had not reported any symptoms.The patient did not bring their patient therapy controller (ptc) to the appointment, so the physician could not test whether or not that device was able to communicate with the pump.The physician theorized that the pump battery had died prematurely but stated that the last inquiry summary report showed the battery to be "ok".The physician had scheduled the patient's pump to be explanted.On the day of the surgery, the physician's staff attempted to connect with the patient's pump again using a clinician programmer.Physician stated that they were able to connect to the device as normal.Physician stated that they inquired, set the daily dose to zero, reset the daily dose to the true value, and repeated this process without fail three times.At this point, the physician decided to refill the pump, and the volume in the reservoir matched up perfectly to the expected volume.The patient is reported to have no symptoms.

• 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: 16910671
• Report Number: 3010079947-2023-00037
• Device Sequence Number: 7562215
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)170801(10)22741
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

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: 08/01/2017
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 22741
• 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: 04/18/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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: Female