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

Catalog Number 4C8723

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot number: it was reported that there are a possible 5 lot numbers associated with the event: r15k02049, r15k03062, r15h18073, r15g15105 and r15e26049.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a blood tubing set leaked during administration.The tubing glued into the spike came out and caused an entire unit of blood to pour out onto the floor.There was no blood loss to the patient.The reporter stated they set up the plasma lite iv bag with the blood tubing set y-connection and then in the morning they hooked up the blood unit bag to the other end of the blood tubing y- site connection.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The reported lots were manufactured: r15k02049 on 11/03/2015, r15k03062 on 11/04/2015, r15h18073 on 08/19/2015, r15g15105 on 07/16/2015, r15e26049 on 05/27/2015.The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the picture and found the tubing separated from the spike.The reported condition was verified.The cause of the condition could not be determined.An ncr has been opened to address this issue.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; 600 mts oeste de entrada; cartago ; CS
• Manufacturer (Section G): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago ; CS
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5543916
• MDR Text Key: 41767903
• Report Number: 1416980-2016-06434
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2016

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 Operator: Health Professional
• Device Expiration Date: 07/15/2020
• Device Catalogue Number: 4C8723
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1