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

Model Number	16827
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Lethargy (2560)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending device return for analysis.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.Internal complaint number: (b)(4).
Event or Problem Description
Sales representative contacted technical solutions via email to report a prometra ii 40 ml pump with an underinfusion volume discrepancy.The expected volume was 8ml and the actual aspirated volume was 30ml.The physician performed a catheter dye study in which the catheter was determined to be patent.Later communication from the physician confirmed that the patient was lethargic and was hospitalized.Days later, an overinfusion volume discrepancy was observed.The expected volume was 36ml and the actual aspirated volume was 27ml.The pump was emptied and turned off and later 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 non-conformances, issues or capas associated with pump function.Additional physical investigation was performed on the device, confirming the alleged issue of underinfusion volume discrepancy.The pump reservior function was checked by filling the reservoir with 20ml of sterile water for injection and allowing the reservoir's pressure to return the fluid into the syringe.The reservoir was refilled and the cap was flushed with 5ml of swi.A demand bolus of 0.3mg with a 1.00mg/ml concentration over 16 minutes was programmed.At ambient temperature, no fluid droplets were observed at the tip of the stem.A second demand bolus, programmed with the same parameters, at 37 degrees celsius, did not produce any fluid droplets at the tip of the stem.The pump was programmed with a 1.994mg daily dose multi-rate flow test over a 24-hour time period at 37 degrees celsius.The dispensed volume was 0.0ml (0.0%) of the expected volume.The catheter access port and suture ring were removed and the pump was decontaminated a second time.A magnet flush was performed with the suture ring and cap off, and the fluid was just dripping out.An additional multi-rate flow test was performed and yielded a result of 0.0ml of the expected volume.The allegation of overinfusion volume discrepancy was not confirmed or observed during the investigation.Further analysis of the valves will be captured in capa 00065.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
• MDR Report Key: 11806342
• Report Number: 3010079947-2021-00135
• Device Sequence Number: 16953169
• Product Code: LKK
• UDI-Device Identifier: 00810335020242
• UDI-Public: (01)00810335020242(10)27159(17)211110
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: 11/10/2021
• Device Model Number: 16827
• Device Catalogue Number: 16827
• Device Lot Number: 27159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 08/24/2021
• 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: Hospitalization; Required Intervention