MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2H8603

Device Problem Defective Device (2588)

Patient Problem Embolus (1830)

Event Date 07/19/2017

Event Type  malfunction  

Event Description

On a previous shift, tpn line picc reported to be clotted and alteplase was ordered.Tpn was turned off.Iv rn in to assess picc line and noticed blood backing up into the tpn line tubing.Tpn line was removed, port was flushed without difficulty, did not need alteplase.Tpn was re-started with new tubing and filter.When old tubing was removed, filter from tpn line appeared to be defective.The filter was saved and given to another rn for further assessment.

• Brand Name: CLEARLINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 911 north davis; cleveland MS 38732
• MDR Report Key: 6776992
• MDR Text Key: 82173854
• Report Number: 6776992
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 2H8603
• Device Catalogue Number: 2H8603
• Device Lot Number: (10)R17D24102
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 100