MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO CLEARLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

Catalog Number 4C8723

Device Problem Failure to Infuse (2340)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that no flow was observed with a access blood solution set.The reporter stated that the port where the syringe locking in, was not allowing the solution to flow.This event occurred during patient use.The event was resolved by attaching the syringe to another y-site.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; 600 mts oeste de entrada; cartago ; CS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5978370
• MDR Text Key: 55684321
• Report Number: 1416980-2016-15631
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4C8723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1