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

Catalog Number JC8723

Device Problems Filling Problem (1233); Obstruction of Flow (2423); No Flow (2991)

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

Event Type  malfunction  

Event Description

It was reported that an unspecified quantity of clearlink system y-type blood/solution sets were unable to properly flush or had slower drip rates than expected.It was also reported that the blood in the bottom chamber of the tubing (the one below the filter chamber) appeared to contain some coagulated blood and some of the nurses reported seeing clots of coagulated blood in the chamber.These issues were identified during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(6).G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B5: an estimated 100ml of blood was not transfused into the patients.D4: lot #: add: r22j29093 (remove: ni).D4: expiration date: add october 31, 2027 (remove: ni).D4: unique identifier: add: (b)(6) (remove ni).The actual device was not available; however, a photograph of the sample was provided for evaluation.The photograph was visually inspected and it was not possible to observe the issues by review of the photograph.The reported condition was not verified.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 CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17326292
• MDR Text Key: 319253333
• Report Number: 1416980-2023-03569
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412152776
• UDI-Public: (01)00085412152776
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JC8723
• Device Lot Number: R22J29093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• 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: Initial
• Patient Sequence Number: 1
• Treatment: 0.9% NORMAL SALINE