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

Model Number 2H8671

Device Problems Break (1069); Failure to Disconnect (2541); No Flow (2991)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

Hanging patient's total parenteral nutrition (tpn), tpn not flowing through tpn filter.Rn flushed normal saline, tpn not infusing, only normal saline.Rn attempted to disconnect tpn filter from iv tubing, unable to, attempted to twist hub w/ tourniquet for friction.Iv tubing broke.Rn reported to clinical manager.Tpn filter, lot (10) r22c01116.

• Brand Name: CLEARLINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15390765
• MDR Text Key: 299581668
• Report Number: 15390765
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412080956
• UDI-Public: (01)00085412080956
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2H8671
• Device Catalogue Number: 2H8671
• Device Lot Number: (10) R22C01116
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1