ALTHIN
Received Aug 11, 1994 · Event occurred Jul 22, 1994
Report 2243621-1994-00294 · MDR key 19249
Device
Product problems
- Loose or Intermittent Connection
Patient
54 YR
- Hemodialysis
Narrative
Description of Event or Problem
FACILITE ALLEGES ARTERIAL BLOOD LINE CAME LOOSE FROM ADAPTER DURING DIALYSIS, RESULTING IN BLOOD SPILLAGE OF > 100CC. BLOOD CIRCUIT DISCARDED; PT RESTARTED ON NEW DIALYZER WITHOUT INCIDENT. GIVEN REPLACEMENT VOLUME OF 200 CC N.G. NO FURTHEER MEDICAL INTERVENTION REQUIRED.