MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SPRAY SETS; SEALANT,POLYMERIZING

Catalog Number 0600021

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericardial Effusion (3271)

Event Date 02/19/2024

Event Type  Injury  

Manufacturer Narrative

E1: initial reporter address: (b)(6).E1: initial reporter city: (b)(6).G1: device manufacturer postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A pediatric patient underwent open heart surgery wherein coseal surgical sealant was applied via an easyspray device with coseal spray set.Five days post operative (postop) the patient had an echocardiograph and confirmed pericardial effusion.That same day the patient started on unspecified medications for treatment of the pericardial effusion.The next day, a second echocardiograph was performed, and no improvement was noted.The patient underwent a pericardial drainage procedure, and a drainage duct was placed.The patient was hospitalized the same day.Eight days postop the patient had recovered.No further information was available at the time of this report.

Manufacturer Narrative

H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SPRAY SETS
• Type of Device: SEALANT,POLYMERIZING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - LESSINES; boulevard rene branquart 80; lessines ; BE
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18939266
• MDR Text Key: 338073257
• Report Number: 1416980-2024-01226
• Device Sequence Number: 1
• Product Code: NBE
• UDI-Device Identifier: 00085412087788
• UDI-Public: (01)00085412087788
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PMA P030039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0600021
• Device Lot Number: 32023492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• 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: COSEAL.; SPRAY SET REGULATOR.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 3 KG