MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. INTERLINK; SET, BLOOD TRANSFUSION

Model Number 2C6700

Device Problem Connection Problem (2900)

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

Event Date 09/26/2022

Event Type  malfunction  

Event Description

Straight blood set, product# 2c6700, lot# (10)r22d06048, administering 1 bag of platelets.Tubing primed, but connector on end of tubing would not connect to male adapter plug, or any other port on any another tubing tried.New set opened and worked appropriately.Approximately 30ml platelets "lost" in first primed set.Manufacturer response for iv tubing, iv tubing (per site reporter) ongoing issue.

• Brand Name: INTERLINK
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15657315
• MDR Text Key: 302279736
• Report Number: 15657315
• Device Sequence Number: 1
• Product Code: BRZ
• 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: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2C6700
• Device Catalogue Number: 2C6700
• Device Lot Number: R22D06048
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1