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

Model Number	16827
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional 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, a definitive root cause could not be determined.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).
Event or Problem Description
Reporter contacted technical solutions to report error codes 100, 103, and 116 that showed when they attempted to inquire a patient's pump.They reported that they had emptied and refilled the pump prior to inquiring it, and the error codes appeared when they first attempted inquiry.Reporter stated that the patient was hospitalized due to pneumonia for several weeks prior to this event.The patient reported increased spasms that started two weeks ago, around the time they had a ct scan.The patient also reported spasms in their stomach, which they had not experienced before.Reporter stated that the patient has not undergone any mris recently and that their oral dose of neurontin had recently been decreased.Technical solutions asked the reporter to program an "emergency pump stop" followed by a demand bolus of 0 mg for 1 minute.Reporter was able to program the pump stop, but the programmer displayed "pump communication failed" each time they tried to enter the bolus menu.Reporter attempted this three times, each with the same result.Technical solutions provided the reporter with contact information for the director of clinical engineering so the reporter could coordinate a time for the director to perform a pump reset and restore.Director of clinical engineering later reported that they were unable to program the pump reset on the patient's pump.A pump replacement is planned, but has not yet been scheduled.

• 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
• 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: 16385630
• Report Number: 3010079947-2023-00012
• Device Sequence Number: 5087338
• Product Code: LKK
• UDI-Device Identifier: 00810335020242
• UDI-Public: (01)00810335020242(10)27081(17)210423
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2021
• Device Model Number: 16827
• Device Catalogue Number: 16827
• Device Lot Number: 27081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male