PURASTAT

Description of Event or Problem

MANUFACTURER RECEIVED A MEDWATCH REPORT DESCRIBING A DEVICE MALFUNCTION DURING PATIENT USE. EVENT DESCRIPTION FROM HEALTH PROFESSIONAL: DESCRIBE THE EVENT OR PROBLEM: FROM STAFF: PATIENT WAS AN ACTIVE BLEED DURING THE PROCEDURE RECEIVING BLOOD TRANSFUSION. MULTIPLE TYPES OF INTERVENTION WERE DONE AND THE PURA STAT WAS DELAYING CARE. A SECOND SYRINGE OF PURA STAT WAS USED WITHOUT DIFFICULTY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? EGD. WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING); DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN;