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 Dizziness (2194); Lethargy (2560)

Event Date 06/18/2022

Event Type  Injury  

Event Description

A patient contacted technical solutions to report a pocket fill that occurred at their last refill.They reported that a nurse performed a routine pump refill and shortly after the refill, they became dizzy and lethargic.The nurse reportedly delivered narcan to the patient and drained their pump prior to calling emergency services.Patient stated that there was a pocket fill of 12-13ml as less than 8ml was taken out of the pump.The patient was not admitted to the hospital, but were in the emergency room for observation for several hours.Patient reportedly left feeling fine and back to normal.Follow up attempts to the patient's reported nurse were unsuccessful.

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.The alleged issue was reported by the patient, but not able to be confirmed by the patient's nurse.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).

Event Description

Per follow-up with nurse, they were unable to confirm this event occurred.Nurse reportedly did not see the patient in the month the event was reported and stated they are the only nurse that sees this patient.

Manufacturer Narrative

No further information regarding the patient's alleged event could be identified.A supplemental mdr will be sent if additional information becomes available.Internal complaint number: (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: 15854044
• MDR Text Key: 304208464
• Report Number: 3010079947-2022-00197
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2021
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 27294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2020
• 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
• Patient Sex: Female