1)SINGLE NEEDLE ( CO-AXIAL FLOW) DIALYSIS KIT

Description of Event or Problem

A PERITONEAL DIALYSIS NURSE REPORTED THAT 3 3/4 HOURS IN TO A SCHEDULED 4 HOUR HEMODIALYSIS TREATMENT, MACHINE WAS ALARMING AND PATIENT WAS FOUND VOMITING AND UNCONSCIOUS, B/P 57 /37; PULSE 65. WHEN STAFF ATTEMPTED TO ADMINISTER NORMAL SALINE IT WAS FOUND THAT BOTH ARTERIAL AND VENOUS NEEDLES WERE DISLODGED DUE TO THE 3M TAPE. EBT. ON FLOOR 200ML. PATIENT WAS RE-CANNULATED WITH A NEW FISTULA NEEDLE AND A TOTAL OF 400ML NORMAL SALINE WAS ADMINISTERED; OXYGEN WAS APPLIED AND EMS WAS CALLED, PATIENT WAS TRANSPORTED TO HOSPITAL WHERE THE PATIENT LATER. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).