InjuryFKY

CENTURY SYSTEM BLOOD TUBING

Received Jan 10, 1994 · Event occurred Nov 23, 1993

Report 2243621-1993-00249 · MDR key 15276

Device

Generic name

Bloodline (venous)

Manufacturer

Cobe Gambro Hospal

Model number

018-440-500

Catalog number

018-440-500

Lot number

0943326

Patient

41 YR

Narrative

Description of Event or Problem

FACILITY ALLEGED THAT AFTER HEMODIALYSIS TREATMENT WAS INITATED AIR WAS DRAWN INTO EXTRACORPORSAL SYSTEM. SOURCE SITE APPEARED TO BE AT VENOUS END OF DIALYZER BLOODLINE CONNEECTING PIECE. EBL 200CC. TREATMENT WAS RESTARTED WITH NEW BLOODLINE WITHOUT FURTHER INCIDENT FACILITY NOT CERTAIN IF LEAK CAME FROM A CRACK IN THE DIALYZER OR LEUR END OF VENOUS BLOODLINE AS BOTH WERE DISCARDED. THIS WAS REPORTED BY A HEALTH CARE PROFESSIONAL.