MAUDE Adverse Event Report: FLOWONIX FLOWONIX PUMP; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number FLOWONIX PUMP

Device Problems Break (1069); No Flow (2991); Output Problem (3005)

Patient Problem Rash (2033)

Event Date 11/08/2021

Event Type  Injury  

Event Description

The patient stated that they had a flowonix pump and when he had to have an mri they would have to remove the medication from the pump in order for him to have an mri of his head because they were trying to find out what was wrong with him.Pt states "come to find out i had a line that was crushed and i wasn't getting my medicine and i was going through withdrawals off an on for about 6 months." pt states "they thought i had covid off and on for 6 months and it damn near killed me".Pt states the ors wouldnt test the pump and it took him 5-6 months to test the pump.They thought it was covid, then they thought it was his blood pressure which was 128/72 when they put me in the hospital for a week.I was not getting any medication and was in pain all the time i was curled up in the fetal position, i thought it was covid, withdrawals are like the flu.Pt states he had dilaudid in the pump and has no idea the dose and concentration.Pt states it was determined the "line was crushed about 1-2 months before (b)(6) 2020 as he got some kind of rash on his back that he feels was from the pain pump, but no one would admit to that.He put anti-inflammatory and creams to get rid of the rash and then they replaced the pump and catheter.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: FLOWONIX PUMP
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): FLOWONIX
• MDR Report Key: 17536648
• MDR Text Key: 321160535
• Report Number: MW5143532
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: FLOWONIX PUMP
• Patient Sequence Number: 1