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

Model Number	11827
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); No Flow (2991)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Patient Problem/Medical Problem (2688)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint number: complaint- (b)(4).Results pending completion of investigation.
Event or Problem Description
It was reported that the patient experienced increased pain.A revision procedure was performed and it was observed that the pump would not flow.The pump was subsequently explanted.
Additional 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 nonconformances, issues or capas associated with pump function.Additional physical investigation was performed on the device, confirming the alleged issue.The investigation confirmed an issue with the pump's flow.An analysis of the inlet and outlet valves confirmed that the inlet valve required a pull open current that exceeded specification.Internal complaint number: complaint (b)(4).
Event or Problem Description
Sales representative contacted technical solutions to report a patient's pump that was explanted.Representative stated that initially an underinfusion volume discrepancy was observed, with an expected volume of 14.5ml and an actual aspirated volume was 17ml.Representative reported that the battery level was "ok" and that there were no error messages.When the physician additionally disconnected the pump from the catheter there was significant csf back-flow.The physician then manually pushed saline through the cap port then decided to put saline into the reservoir to run the bolus.Technical solutions instructed the representative to program a pump prime when the catheter was disconnected from the pump, and the doctor saw one small bead form at the end, but it did not drip.The physician determined that the pump should be replaced since there was medication already in the pds which should have pushed additional volume out of the stem.However, the pump was not warmed when it was primed/disconnected from the pump.

• Brand Name: PROMETRA PROGRAMMABLE PUMP
• Common Device Name: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): FLOWONIX MEDICAL, INC; 500 international drive; suite 200; mount olive NJ 07828
• MDR Report Key: 8778060
• Report Number: 3010079947-2019-00094
• Device Sequence Number: 19332804
• Product Code: LKK
• UDI-Device Identifier: 00810335020082
• UDI-Public: 0100810335020082101972017160925
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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: 09/25/2016
• Device Model Number: 11827
• Device Catalogue Number: 11827
• Device Lot Number: 19720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention