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

Model Number 13827

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Memory Loss/Impairment (1958); Discomfort (2330); Inadequate Pain Relief (2388); Unspecified Nervous System Problem (4426)

Event Date 06/20/2022

Event Type  Injury  

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.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).

Event Description

Representative contacted technical solutions after a cap study was performed on a patient after a volume discrepancy was noticed at the patient's last refill.Representative stated that the catheter was found to be patent.Representative also reported that the patient went through severe withdrawal symptoms and was in the emergency room for two days.Additional communication confirmed that the patient was given opiates and released from the hospital.It was also stated that the patient has "other neuro issues and memory issues" and is being followed by a neurologist.Representative stated that the cause of the issue is unknown at this point.

Manufacturer Narrative

Additional information: b2, b5, b6, d6b.Corrected information: d9, h3, h6.Pending completion of device analysis.Internal complaint number: complaint-05610.

Event Description

Agent contacted technical solutions to report additional information.Agent stated that the patient had another dye study, which showed a patent catheter.The patient still reported a lack of pain relief.The physician decided to do a pump replacement.At the latest inquiry report, another underinfusion volume discrepancy was observed with the expected volume being 2.79ml and the actual aspirated volume being 19ml.A priming bolus was performed after a nurse filled the pump with saline, and a bead formation was observed at the pump stem tip.

Manufacturer Narrative

Corrected information: h3, h6 device was returned for additional evaluation and investigation.Additional physical investigation was performed on the device, confirming the alleged issue.Visual inspection of the pump did not find any anomaly with the pump's exterior.Operation of the pump reservoir function was checked by filling the reservoir with 20 ml of sterile water for injection (swi) and allowing the reservoir's pressure to return the fluid into the syringe.The reservoir was refilled and the cap was flushed with 5 ml of swi.A demand bolus of 0.300 mg with a 1.00 mg/ml concentration over 16 minutes was programmed with a programmer.The pump was able to prime at ambient temperature and at 37°c.The pump was programmed with a 1.994 mg daily dose multi-rate flow test over a 24-hour time period at 37°c for 1 day.The dispensed volume was 0 ml (0%) of the expected volume.Engineering emptied the pump's reservoir and refilled it with a 0.01 m of naoh (sodium hydroxide) solution.The solution is a mild caustic solution that will help decompose proteins and fats, which will easily dissolve in water and be removed from the flow path.After running this naoh solution through the flow path, the pump's flow significantly improved from 0% to 82% efficiency.As noted in the prometra® ii pump 20 ml (ref 13827) and prometra® ii pump 40 ml (ref 16827) instructions for use (ifu): the prometra® programmable infusion pump system is indicated for intrathecal infusion of drug therapy, including: infumorph ® (preservative free morphine sulfate sterile solution), preservative-free sterile 0.9% saline solution (sodium chloride injection, usp), and baclofen (baclofen injection, intrathecal, 500-2000 mcg/ml).Use of unapproved drugs (e.G., drug cocktails, pharmacy compounded drugs, morphine with preservatives, etc.) with the prometra ii pump could result in pump failure.This pump was reported to contain morphine as its primary drug.It is likely that the drug(s) used in the pump affected the flow path and/or the materials located in the interior of the pump.Internal complaint number: complaint-(b)(4).

• Brand Name: PROMETRA II PROGRAMMABLE PUMP
• Type of Device: 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: 15085872
• MDR Text Key: 296405220
• Report Number: 3010079947-2022-00131
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)210724(10)26673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2021
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 26673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 08/05/2022; 08/05/2022
• Supplement Dates FDA Received: 09/02/2022; 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female