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

Model Number	11827
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Follow-up is pending regarding patient status.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 was not returned for additional evaluation and investigation.If additional information becomes available, a supplemental mdr will be sent.The issue was determined to be related to the proper mri procedures not being followed.Internal complaint number: (b)(4).
Event or Problem Description
Clinical specialist (cs) contacted technical solutions to report a patient that went through mri without emptying or stopping their pump.The patient originally went to emergency room with stroke-like symptoms and the hospital wanted to do an mri of the patient's brain.It was stated that the patient's husband informed the hospital employees that the patient had a pain pump and provided them with a card.The type of card has not been confirmed at this time.The hospital reportedly stated they would contact the company before they did the scan, but per receipt of the call to technical solutions, the scan had already been performed when they were contacted.Following the mri, the patient was getting off the table, and began having "seizure-like activity and jerking movements." the patient was sedated and admitted to the hospital icu.An agent turned the patient's pump off.The next day, the cs accessed the patient's pump and observed that no medication came out.Additional communication confirmed that the patient has developed pneumonia and is on a ventilator.It was stated that the pneumonia may be related to being on the ventilator, in combination with the positioning of the patient.It has not been confirmed whether the patient was ever off the ventilator.Patient is receiving pain medication through their iv, and it is not known if they are still sedated or not.
Additional Manufacturer Narrative
If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).
Event or Problem Description
Clinical specialist (cs) stated that they had spoke to the attending physician and confirmed that the patient is responsive and awake.It was also stated that the patient has a trach, and if plugged, can somewhat start verbalizing.No further information was provided.
Additional Manufacturer Narrative
Additional information: d6a 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: 12053780
• Report Number: 3010079947-2021-00177
• Device Sequence Number: 3592451
• Product Code: LKK
• UDI-Device Identifier: 00810335020082
• UDI-Public: (01)00810335020082(10)20231(17)170323
• 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
• 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): 05/25/2021

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: 03/23/2017
• Device Model Number: 11827
• Device Catalogue Number: 11827
• Device Lot Number: 20231
• 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: 05/25/2021
• Supplement Date Received by Manufacturer: 07/07/2021; 06/27/2022
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/28/2021; 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2015
• 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: Hospitalization; Required Intervention
• Patient Sex: Female