MalfunctionFKB
DIAL MEDICAL SUPPLY
Received Jan 24, 1995 · Event occurred Dec 5, 1994
Report 1051129-1994-00015 · MDR key 21109
Device
Generic name
Hemodialysis Blood Tubing
Manufacturer
Manufacturas Arriol C. Por A.Model number
NACatalog number
B4-310
Lot number
A4F08
Product problems
- Loose or Intermittent Connection
Patient
57 YR
- Hemodialysis
Narrative
Description of Event or Problem
ONE HR INTO PT'S HEMODIALYSIS TREATMENT, TUBING BEGAN TO HAVE AIR IN SYSTEM-ESPECIALLY ARTERIAL CHAMBER. UPON CLOSEER INSPECTION, END-USER NOTICED AIR COMING INTO TUBING SYSTEM AT CONNECTION ON ARTERIAL TUBINGWHERE THE BLOOD PUMP ROTATES. CONNECTION "CAME-APART" AND WAS ALLOWING AIR TO ENTER. ARTERIAL SIDE OF TUBING WAS CHANGED. T EXPERIENCED NO ADVERSE EVENT.