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

Model Number 13827

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problems Pocket Erosion (2013); Patient Problem/Medical Problem (2688)

Event Date 04/09/2020

Event Type  Injury  

Manufacturer Narrative

Pending follow-up from reporter, including specific device information.(b)(4).

Event Description

Received voluntary medwatch 5094218 from fda.Health professional reported a prometra ii pump that may be explanted due to alleged erosion.Report states, "patient was implanted with prometra ii flowonix pump 2017.The pump was placed in the left rear flank and was in approved location.The pump was refilled multiple times until noticed in 2020 that there was an erosion directly above the protruding nipple of the refill port.Unlike other devices on the market (mdt synchromed ii) the refill port is elevated above the plane of the device.This produces contact on the overlying dermal layers and could cause this failure.Now, due to covid-19, we are reluctant to go to hospital to replace or remove.Managing with oral antibiotics and reducing dose.".

Event Description

Received voluntary medwatch 5094218 from fda.Health professional reported a prometra ii pump that may be explanted due to alleged erosion.Report states, "patient was implanted with prometra ii flowonix pump 2017.The pump was placed in the left rear flank and was in approved location.The pump was refilled multiple times until noticed in 2020 that there was an erosion directly above the protruding nipple of the refill port.Unlike other devices on the market (mdt synchromed ii) the refill port is elevated above the plane of the device.This produces contact on the overlying dermal layers and could cause this failure.Now, due to covd-19, we are reluctant to go to hospital to replace or remove.Managing with oral antibiotics and reducing dose." per follow-up, physician reported that patient is also being treated with wound care.Physician opted to turn off the pump at this time.

Manufacturer Narrative

Additional data: serial #, lot #, expiration date, udi #).Corrected data: (model #, catalog #).Performed dhr review 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.Per follow-up with physician, patient has a "sedentary lifestyle." requested contact from physician if/when explant surgery occurs.Internal complaint # - (b)(4).

Event Description

Received voluntary medwatch 5094218 from fda.Health professional reported a prometra ii pump that may be explanted due to alleged erosion.Report states, "patient was implanted with prometra ii flowonix pump 2017.The pump was placed in the left rear flank and was in approved location.The pump was refilled multiple times until noticed in 2020 that there was an erosion directly above the protruding nipple of the refill port.Unlike other devices on the market (mdt synchromed ii) the refill port is elevated above the plane of the device.This produces contact on the overlying dermal layers and could cause this failure.Now, due to covd-19, we are reluctant to go to hospital to replace or remove.Managing with oral antibiotics and reducing dose." per follow-up, physician reported that patient was also being treated with wound care.Physician opted to turn off the pump and then explanted the pump.Physician additionally reported a "disconnect at the pump stem." per the physician, the disconnect, "let the medication in the pump blow by the catheter and dribble into the pocket.".

Manufacturer Narrative

Device was unable to be analyzed as it was discarded.The alleged disconnection at the pump stem could not be confirmed as the pump was not returned for analysis.There was no further information provided and potential root cause for the erosion could not be determined.Per instructions for use, 'pump site skin erosion' is included as one of the 'possible risks associated with programmable implantable pump'.If additional information is received, a supplemental report will be submitted.Internal 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
• MDR Report Key: 10017772
• MDR Text Key: 189627281
• Report Number: 3010079947-2020-00232
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2017
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 22676
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention