MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS SMARTSITE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 30204E

Device Problems Crack (1135); Fluid/Blood Leak (1250); Defective Device (2588); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2021

Event Type  malfunction  

Event Description

After pressing run procedure "no replacement fluid detected" alarmed and it was noted that blood was leaking from the draw line.Lines were clamped and it was found that the cause was the extension tubing was defective/cracked.

• Brand Name: ALARIS SMARTSITE EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 12567940
• MDR Text Key: 274528669
• Report Number: 12567940
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 30204E
• Device Catalogue Number: 30204E
• Device Lot Number: 21039703
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10585 DA