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

Catalog Number	0600021
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1416980-2024-01226
• Device Sequence Number: 7026902
• Product Code: NBE
• UDI-Device Identifier: 00085412087788
• UDI-Public: (01)00085412087788
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: PMA P030039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0600021
• Device Lot Number: 32023492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COSEAL.; SPRAY SET REGULATOR.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 3 KG