inforMED
OtherLIF

RENALIN

Received Dec 30, 2004 · Event occurred Dec 3, 2004

Report 2150060-2004-00037 · MDR key 562610

Device

Generic name

Cold Sterilant

Manufacturer

Minntech Corp.

Model number

NA

Catalog number

NA

Lot number

NA

Product problems

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

Patient

NA

  • Visual Disturbances
  • Burning Sensation
  • Therapy/non-surgical treatment/delayed/prolonged

Narrative

Description of Event or Problem

PT COMPLAINED OF BURNING SENSATION AT THE VENOUS RETURN AT THE BEGINNING OF TREATMENT. PT ALSO STATED THEY FELT LIKE THEY WERE GOING BLIND. PT CARE PEOPLE THOUGHT IT WAS A RENALIN REACTION SO TREATMENT WAS IMMEDIATELY STOPPED. SYMPTOMS WENT AWAY AS SOON AS TREATMENT WAS STOPPED. STAFF REPORTED THE DIALYZER SHOWED BLOOD TO BE DARKER ON ONE END THAN ON THE OTHER. PT WAS REINITIATED ON A DRY PACK DIALYZER AND TREATMENT WAS COMPLETED WITHOUT FURTHER INCIDENT. NO HOSPITALIZATION WAS REQUIRED. PT DOING FINE, WITH NO ILL EFFECTS BEING REPORTED.