FDA Adverse Event Death Summary report: N

MERIT MEDICAL SYSTEMS INC.

MDR report key: 131469 · Received November 6, 1997

Report

Report Number
131469
Event Type
Death
Date Received
November 6, 1997
Date of Event
October 16, 1997
Report Date
October 23, 1997
Manufacturer
MERIT MEDICAL SYSTEMS INC.
Product Code
DTL
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
TN, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

PATIENT PLACED ON TABLE IN CATH LAB AND GIVEN I.V. SEDATION. ROOM WAS SET UP TO DELIVER SALINE AND CONTRAST SOLUTION AND MONITOR ARTERIAL BLOOD PRESSURE THROUGH A MERIT MEDICAL MANIFOLD. 500ML BAG OF SALINE WAS ATTACHED TO MANIFOLD, 150 ML BAG OF CONTRAST AND A PRESSURE TRANSDUCER, CATHETER WAS INSERTED IN RIGHT HEART AND 5 IMAGES WERE TAKEN. CATHETER REMOVED AND INSERTED INTO LEFT HEART WHERE 2 IMAGES WERE TAKEN. AT THIS POINT PATIENT LOST ALL ARTERIAL PRESSURE AND SA02 WAS DROPPING RAPIDLY. NO PULSE COULD BE FOUND. CPR WAS PERFORMED AND PATIENT WAS SUCCESSFULLY RESUSCITATED. IT WAS NOTED THAT THE SALINE AND CONTRAST BAGS WERE EMPTY AND THAT AIR WAS IN THE TUBING. PATIENT WAS TRANSPORTED TO THE C.C.U. WHERE HE DIED AND ALL RESUSCITATION ATTEMPTS WERE UNSUCCESSFUL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MERIT MEDICAL SYSTEMS INC. I.V. MANIFOLD DTL MERIT MEDICAL SYSTEMS INC. * EITHER 810644 OR 971047

Patients

Seq Age Sex Outcome Treatment
1 40 YR Death