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

Device Problems Use of Device Problem (1670); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported the patient had a flowonix catheter that they were unable to aspirate.The drug in the catheter was 700 mcg/ml and the drug in the reservoir and added 8578 is 500 mcg/ml.It was noted the volume per cm was 0.0026ml/cm.The flowonix catheter length was 58.2 cm x 0.0026 = 0.151 ml x 700 mcg/ml = 105.7 mcg/ 85 mcg/day = 1.243 days x 24hr = 29 hrs and 50 mins.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): FLOWONIX
• MDR Report Key: 17531129
• MDR Text Key: 321419356
• Report Number: MW5138044
• 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: 03/22/2021

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
• Patient Sequence Number: 1