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

Model Number MX448HFB

Device Problems Difficult to Flush (1251); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2023

Event Type  malfunction  

Event Description

I was hanging my tpn and lipids for the patient in the late evening.After i got a second rn signature, and started them, the lipid line kept beeping occluded.I and rn 2 tried to flush the lipids from two different port sites, but it just kept backing up into the rubber part of the alaris tubing into a big bubble.We ended up having to get a new extension set with a filter and waste the product that was in the extension set that wasn't flushing.

• Brand Name: MEDEX
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 16918481
• MDR Text Key: 315087237
• Report Number: 16918481
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model 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: 04/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1825 DA
• Patient Sex: Female