MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; FILTER, INFUSION LINE

Model Number MX448HFB

Device Problems Obstruction of Flow (2423); Audible Prompt/Feedback Problem (4020)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2023

Event Type  malfunction  

Event Description

Iv pump alarming occlusion, clamps open, line patent, and no kinks.Upon disconnecting line, no flow.Decided to change filter - line began to flow freely.Filter had been preventing flow for some reason.Happened x2 thus far this shift.

• Brand Name: MEDEX
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 16761249
• MDR Text Key: 313502279
• Report Number: 16761249
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MX448HFB
• Device Catalogue Number: MX448HFB
• Device Lot Number: 4355305
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3650 DA
• Patient Sex: Female