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

Model Number	11827
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Lethargy (2560); Insufficient Information (4580)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending follow up information on overinfusion symptoms 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.Internal complaint number: (b)(4).
Event or Problem Description
Clinical specialist (cs) reported that a physician told them that a patient had symptoms of being possibly over-infused following an mri that was done the previous week.The patient's medication dose was subsequently decreased.Cs stated that they had covered the mri appointment and all proper steps were followed.It is unknown what caused the issue to occur.
Event or Problem Description
Additional communication with clinical specialist (cs) confirmed that the overinfusion symptoms that were alleged were that the patient felt sleepy and overmedicated.
Additional Manufacturer Narrative
Device remains implanted and was not returned.No explant has been scheduled.Physician said as long as there is no significant discrepancy at the patient's next refill, they will wait and do a replacement closer to end of life of pump.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).
Event or Problem Description
Additional communication confirmed that the patient's pump was explanted due to the age of pump and the physician believing that it was time for a replacement.The pump was discarded.Patient symptoms were said to have improved prior to surgery.
Additional Manufacturer Narrative
Device was explanted and discarded.The device was not returned for additional evaluation and investigation.It was stated that the patient's symptoms had improved prior to the pump explant, but that the device was replaced due to device age.As no physical investigation was performed on the device, a definitive root cause for the original alleged issue could not be confirmed.Internal complaint number: (b)(4).

• Brand Name: PROMETRA 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: 13172215
• Report Number: 3010079947-2022-00001
• Device Sequence Number: 4485580
• Product Code: LKK
• UDI-Device Identifier: 00810335020082
• UDI-Public: (01)00810335020082(17)170203(10)20090
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/03/2017
• Device Model Number: 11827
• Device Catalogue Number: 11827
• Device Lot Number: 20090
• 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: 12/06/2021
• Supplement Date Received by Manufacturer: 01/10/2021; 03/03/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 01/20/2022; 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2015
• 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
• Outcome Attributed to Adverse Event: Other; Other
• Patient Sex: Female