MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SYRINGE, PISTON

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

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 09/30/2022

Event Type  Injury  

Event Description

A patient underwent a prostatectomy procedure in which an unknown duplospray applicator was used.It was reported during application of tisseel via the duplospray with 360 applicator, the patient¿s blood pressure dropped ¿dramatically¿.The use of the duplospray was stopped.The patient was placed in steep trendelenburg position.Fluids and vasopressors were administered and reduced pneumoperitoneum to less than 5mm was applied.The patient recovered within ¿5 minutes or less with no postop sequelae".No additional information is available.

Manufacturer Narrative

(b)(6).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.

Manufacturer Narrative

Upon further review, it was determined that this device is a non-baxter product.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 15996045
• MDR Text Key: 305605945
• Report Number: 1416980-2022-06902
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2023
• 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: TISSEEL
• Patient Outcome(s): Required Intervention