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 Problem Loss of consciousness (2418)

Event Date 03/31/2023

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.Several attempts were made to contact the physician's office for additional information, but the attempts were unsuccessful.Per the patient's request, technical support provided a list of alternate doctors in the patient's area.Per the instructions for use of the device, refill errors such as pocket fill are known possible risks of use of the device.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).

Event Description

Patient contacted technical solutions to report an issue that occurred at their most recent refill appointment.They reported that after their refill, they fell unconscious and were administered three doses of narcan.They were then sent to the hospital and had recovered by the time they called technical solutions.The patient also reported that a new clinician began performing their refills around two months prior to the issue.The patient stated that they had asked the clinician to perform the refill without performing a sonogram first.The patient believed that the adverse symptoms they experienced were due to the clinician not emptying the pump before performing the refill.

Manufacturer Narrative

Additional information was provided which confirmed that the patient could not remember what type of medication was in their pump, but reported that they took additional prescribed oral medications.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: 16753875
• MDR Text Key: 313437489
• Report Number: 3010079947-2023-00028
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)180502(10)23636
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2018
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 23636
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2017
• 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