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

Model Number	16827
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Inadequate Pain Relief (2388)
Date of Event	01/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Flowonix initially received a report about a patient alleging unrelieved pain and a potential device malfunction.The agent covering the issue reported that there were no volume discrepancies.The agent reported that the office increased the daily dose by 1-2% each visit, and the patient was then scheduled to have a dye study performed.A dye study was later performed, which showed that drug was not flowing from the catheter.Agent reported that the patient requested that the pump be explanted and kept in their possession.The catheter issue was captured in mdr 3010079947-2021-00069.Voluntary mw5114474 was later received from fda.Reporter stated that their spouse had pump implanted after being diagnosed with pancreatic cancer.Doctors implanted a "prometra flowonix pump" which "seemed to stabilize [the patient's] pain"; however shortly afterwards, reporter alleged needing to return to the hospital with the patient "twice weekly/every three days." the patient would have their meds increased, although "several er visits more hospital stays" were reported.A nuclear test was reportedly performed to "check the device" after "3 days of x-rays showed the device was not working".Patient reportedly "had swelling at the incision in [their] back." a surgery was performed to "tighten up the incision area," but swelling reportedly began again afterwards.The device was subsequently removed and reportedly broke during removal.Patient's wife alleged, "[the physician] had to leave a piece of the medical device in the [the patient's] theacal sac." reporter stated patient "suffered horrendous pain until the day of [their] death." no further information provided.
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.As the device was not returned for additional investigation, a definitive root cause for the patient's pain and alleged device issue could not be determined.The report does not clarify believed causality of the patient's death.Per reporter, the health and safety department informed them that "the pain pump was working." per the instructions for use of the device, pump site seroma is a known possible risk of use of the device.A supplemental mdr will be sent if additional information is obtained.Internal complaint number: (b)(4).

• 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: 16351807
• Report Number: 3010079947-2023-00016
• Device Sequence Number: 6836671
• Product Code: LKK
• UDI-Device Identifier: 00810335020242
• UDI-Public: (01)00810335020242(10)26362(17)200916
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/16/2020
• Device Model Number: 16827
• Device Catalogue Number: 16827
• Device Lot Number: 26362
• 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: 01/27/2023
• Initial Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male