MEDLINE

Description of Event or Problem

THE SYRINGE AND MANIFOLD STARTED BECOMING LOOSE.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE "SYRINGE AND MANIFOLD STARTED BECOMING LOOSE. ABOUT 50MLS OF CONTRAST HAD SUCCESSFULLY BEEN INJECTED PRIOR TO THIS. WHEN THE CONNECTION BECAME LOOSE THERE WAS BACKFLOW OF BLOOD AND THE ARTERIAL PRESSURE DROPPED WHICH CONFUSED THE STAFF AND THE PATIENT'S CONDITION DETERIORATED. THIS WAS DURING THE MIDDLE OF THE STEMI WITH THE ANGIOPLASTY BALLOON IN SITU. THE PATIENT HAD VF/VT PRIOR TO THE INCIDENT AND STAFF WERE CONCERNED ABOUT FURTHER DETERIORATION. AGAIN. A NEW HAND INJECTION PK HAD TO BE OPENED CAUSING A FURTHER DELAY TO THE ANGIOPLASTY." IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Additional Manufacturer Narrative

UPDATED E1, H6.