MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; PRESSURE MONITORING

Model Number TRANSTAR@84IN (213CM)

Device Problem Leak/Splash (1354)

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

Event Date 12/02/2020

Event Type  Injury  

Event Description

Information received a smiths medical pressure monitoring|medex transtar kits malfunctioned.The complaint is reporting interruption of a critical procedure during angio catheterization a patient suffering from anterior and inferior myocardial infarction the event below was reported by facility stated "patient presented with chest pain and sweating at 9, thrombolytic therapy given at 10.Angiography showed severe stenosis of the left main and right coronary arteries and heart attack.Inner 1 was treated with aortic balloon countermeasures.Night shift nurse opened a sensor and connected 0.9% sodium chloride at 22:00, and found leakage at the joint.After rechecking and tightening the joint, there was still leakage.Replaced with a new sensor.".

• Brand Name: MEDEX
• Type of Device: PRESSURE MONITORING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11579563
• MDR Text Key: 242668993
• Report Number: 3012307300-2021-02535
• Device Sequence Number: 1
• Product Code: DPT
• UDI-Device Identifier: 10351688503992
• UDI-Public: 10351688503992
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K942377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2023
• Device Model Number: TRANSTAR@84IN (213CM)
• Device Catalogue Number: MX9505T
• Device Lot Number: 4002470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2020
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 55 YR