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

Model Number 13827

Device Problem Use of Device Problem (1670)

Patient Problems Memory Loss/Impairment (1958); Numbness (2415); Loss of consciousness (2418); Convulsion/Seizure (4406); Unspecified Respiratory Problem (4464)

Event Date 04/28/2022

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-conformance's, issues or capas associated with pump function.Device remains implanted and was not returned.Per the instructions for use of the device, refill errors are known possible risks of use of the device.Internal complaint number: (b)(4).

Event Description

Agent reported a pocket fill that occurred during a refill performed by a nurse practitioner (np).Agent was informed after the pocket fill had occurred and the patient was taken to the hospital.Per follow-up by the agent, it was determined that the refill protocol was not followed during the refill.The np reportedly pulled back only 3ml when they were expecting 7.9ml, which they believed to be normal due to primarily servicing synchromed pumps.The np then pushed in all the drug, reported to be only 6ml of 7.5mg/ml dilaudid and 15mg/ml bupivacaine, in the syringe, without feeling any resistance from the refill septum.There was no attempt to aspirate from the pocket after removal of the needle.The np discarded the syringe and the patient immediately reported, "feeling off, this does not feel right".Agent stated patient was communicative and said their stomach was going numb, were experiencing breathing issues, felt their body going numb, and eventually fell unconscious once on the stretcher at the facility.Patient's pulse ox was hovering around 68 at the time.No narcan was delivered at the facility and ems arrived roughly 10 minutes after the event, at which point the patient was administered narcan, taken to the hospital, and was placed under observation while on a ventilator.Per further follow-up, agent reported that the patient was discharged and brought back to their managing physician's office for a follow-up.During this appointment, upon reaching the septum, the physician pulled back the 7ml that was previously expected at the last refill date.This confirmed for the physician that a pocket fill had occurred previously.Following the appointment, physician contacted the agent and informed them of this information, in addition to confirmation the pocket fill had occurred due to the location of the previous needle mark.The pump had reportedly been missed by several inches during the prior refill.Agent reported that the patient was unable to remember the prior couple weeks following the overdose.Patient also complained of a sore body due to the seizures suffered after the pocket fill.Both patient and doctor agreed to pause therapy for a minimum of two weeks.As of current day, patient is doing much better and recent refill occurred with no issue.

• 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: 14515869
• MDR Text Key: 292740653
• Report Number: 3010079947-2022-00096
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)170616(10)22573
• 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
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2017
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 22573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2016
• 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