PHOENIX

Received Mar 3, 2008 · Event occurred Feb 29, 2008

Report 1024341 · MDR key 1024341

Device

Generic name

Dialysis Machine

Manufacturer

Gambro Renal Products, Inc.

Model number

Catalog number

Lot number

Product problems

Unknown (for use when the device problem is not known)

Patient

8 YR

Vomiting
Reaction
Loss of consciousness
Therapy/non-surgical treatment, aborted/stopped

Narrative

Description of Event or Problem

PT HAD JUST BEEN PLACED ON DIALYSIS WHEN HE HAD A REACTION WHICH WAS VOMITING AND THEN BECAME UNCONSCIOUS. DIALYSIS WAS STOPPED IMMEDIATELY. THE MACHINE WAS CLEANED AND ALL DISPOSABLES CHANGED AND SET UP FOR ANOTHER PATIENT. THE SECOND PATIENT ALSO HAD A REACTION ONCE THEY WERE STARTED ON DIALYSIS WHICH WAS DIZZINESS, TINGLING, FLUSHING, "DO NOT FEEL RIGHT," TREMBLY. ONCE AGAIN, DIALYSIS WAS STOPPED IMMEDIATELY.