OtherFII

2008 HD DELIVERY SYSTEM

Received Sep 24, 1998 · Event occurred Sep 22, 1998

Report MW1014625 · MDR key 188705

Device

Generic name

Hemodialysis Machine

Manufacturer

Fresenius

Model number

UNK

Catalog number

UNK

Lot number

UNK

Product problems

Inadequate Instructions for Healthcare Professional

Patient

Narrative

Description of Event or Problem

RPTR WAS GIVEN A PERMISSION BY CO REP TO USE MACHINE FOR CONTINUOUS RENAL REPLACEMENT THERAPY, WHICH IS AGAINST THE INSTRUCTIONS FOR USE FROM THE MFR. THIS MACHINE HAS BEEN USED FOR INTERMITTENT HEMODIALYSIS ONLY.