MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER CLEAR LINK SYSTEM Y-TYPE BLOOD/SOLUTION SET W/ LARGE STANFORD BLOOD FILTE; SET, BLOOD TRANSFUSION

Model Number 4C8723

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem Exposure to Body Fluids (1745)

Event Date 03/12/2019

Event Type  malfunction  

Event Description

Anesthesia clinician attempted to use the hand pump of a manual blood pump iv set.At the section of the pump, a plastic cylinder glued to a bottom outflow cap and top inflow cap, separated between the inflow cap and the cylinder.This sent blood spraying around the area of the anesthesia station and nearby staff.This is the third set reported and the first we could determine the lot number.Had not yet been used on a pt, therefore no pt info provided.Fda safety report id# (b)(4).

• Brand Name: BAXTER CLEAR LINK SYSTEM Y-TYPE BLOOD/SOLUTION SET W/ LARGE STANFORD BLOOD FILTE
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL 60015
• MDR Report Key: 8518787
• MDR Text Key: 142237634
• Report Number: MW5085889
• Device Sequence Number: 3
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/11/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4C8723
• Device Catalogue Number: BAXTER 4C8723
• Device Lot Number: (10)R18J24117
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1