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

Model Number 13827

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Sleep Dysfunction (2517); Patient Problem/Medical Problem (2688)

Event Date 01/24/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint # - (b)(4).

Event Description

A patient was reported who has had two pocket fills since implant.The patient was implanted on (b)(6) 2018 and was switched from a medtronic system to a flowonix system.The first pocket fill occurred on (b)(6) 2019.(b)(6) 2019: the patient was refilled with 19.3 mls.The patient reports feeling tired and dizzy and goes to the er a few hours after the refill appointment.The physician assistant accesses the pump and the reservoir volume is "about 1 ml off" expected: approximately 19 mls returned: 18 mls it is unknown which refill kit was used.(b)(6) 2019- (b)(6) 2020: the patient has 4 refill appointments over the year.There are no reported issues or errors from these appointments.(b)(6) 2020: the patient was refilled with 19.3 mls.The patient reports feeling tired and sweaty.The patient is brought to the er approximately 2 hours after the refill appointment.The patient is found to have low blood pressure and be hypertensive.The physician assistant accesses the pump and the reservoir volume is reported to be 17 mls.Expected: approximately 19.3 mls returned: 17 mls the patient spends the night in the icu.It was reported that a medtronic refill kit was used at this refill appointment.The patient has since made a full recovery.It was also stated that the physician uses proper technique when refilling the pump.The patient is in constant flow and it is unknown if they have a ptc.The physician plans to explant the pump and replace it.The explant has not yet been scheduled.

Manufacturer Narrative

Device has been explanted and will be returned for evaluation.A review of the dhr, 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 #: complaint - (b)(4).

Event Description

Clinical specialist reported a patient that has had two pocket fills since implant.The patient was implanted on (b)(6) 2018 and was switched from a medtronic system to a flowonix system.(b)(6) 2019: 1.The patient comes in for their scheduled refill.2.The patient is filled with 19.3 mls.3.The patient reports feeling tired and dizzy and goes to the er a few hours after the refill appointment.4.The physician assistant accesses the pump and the reservoir volume is "about 1 ml off" expected: approximately 19 mls; returned: 18 mls.It is unknown if a flowonix refill kit was used.(b)(6) 2019-(b)(6) 2020: the patient has 4 refill appointments over the year.There are no reported issues or errors from these appointments.(b)(6) 2020: 1.The patient comes in for their scheduled refill.2.The patient is refilled with 19.3 mls.3.The patient reports feeling tired and sweaty.4.The patient is brought to the er approximately 2 hours after the refill appointment.5.The patient is found to have low blood pressure and be hypertensive.6.The physician assistant accesses the pump and the reservoir volume is reported to be 17 mls.Expected: approximately 19.3 mls; returned: 17 mls.The patient spent the night in the icu and has since made a full recovery.Clinical specialist reported that a medtronic refill kit was used at this refill appointment, and that the physician uses proper technique when refilling the pump.Pump was explanted on 5/12/2020.

Event Description

Clinical specialist reported a patient that has had two pocket fills since implant.The patient was implanted on 3/7/2018 and was switched from a medtronic system to a flowonix system.(b)(6) 2019: the patient comes in for their scheduled refill.The patient is filled with 19.3 mls.The patient reports feeling tired and dizzy and goes to the er a few hours after the refill appointment.The physician assistant accesses the pump and the reservoir volume is "about 1 ml off".Expected: approximately 19 mls returned: 18 mls it is unknown if a flowonix refill kit was used.(b)(6) 2019-(b)(6) 2020: the patient has 4 refill appointments over the year.There are no reported issues or errors from these appointments.(b)(6) 2020: the patient comes in for their scheduled refill.The patient is refilled with 19.3 mls.The patient reports feeling tired and sweaty.The patient is brought to the er approximately 2 hours after the refill appointment.The patient is found to have low blood pressure and be hypertensive.The physician assistant accesses the pump and the reservoir volume is reported to be 17 mls.Expected: approximately 19.3 mls.Returned: 17 mls.The patient spent the night in the icu and has since made a full recovery.Clinical specialist reported that a medtronic refill kit was used at this refill appointment, and that the physician uses proper technique when refilling the pump.Pump was explanted on (b)(6) 2020.

Manufacturer Narrative

Corrected data: d4 (serial #, lot #, expiration date, udi).Returned pump had a different serial number than initially reported in the complaint.Confirmed with patient tracking that the received pump matches patient initials in complaint.Pending analysis of returned pump.Internal complaint # - complaint (b)(4).

Manufacturer Narrative

Device was returned for additional evaluation and investigation.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 nonconformances, issues or capas associated with pump function.Additional physical investigation was performed on the device, but the issue was not confirmed.Functional analysis of the pump confirmed that the pump successfully primed and flowed within specification.The unit flowed at 99% efficiency.Two sections of the catheter were returned as well, and both were determined to be patent.As the device performed as expected during investigation, no issue or malfunction was found and a root cause could not be confirmed.The issues alleged in this complaint were likely due to a pocket fill by the person performing the refill procedures.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
• MDR Report Key: 9777713
• MDR Text Key: 185474518
• Report Number: 3010079947-2020-00215
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(10)23889(17)180721
• Combination Product (y/n): N
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/18/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2018
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 24011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 05/12/2020; 06/09/2020; 06/09/2020
• Supplement Dates FDA Received: 05/27/2020; 06/22/2020; 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention