MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. INTERLINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1C8581

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

Rn was preparing to administer iec (immune effector cells) cells when she observed that the tubing did not have a second roller clamp on the y set up.Pictures attached to this report.

• Brand Name: INTERLINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 12933079
• MDR Text Key: 281749062
• Report Number: 12933079
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1C8581
• Device Catalogue Number: 1C8581
• Device Lot Number: DR18E30014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1