inforMED
OtherMSZ

FAST FORMALERT

Received Oct 31, 1997 · Event occurred Oct 2, 1997

Report 1647143-1997-00004 · MDR key 129063

Device

Generic name

Test Strip

Manufacturer

Gambro Healthcare

Model number

NA

Catalog number

641964300

Lot number

UNK

Patient

UNKNOWN

Narrative

Description of Event or Problem

REUSE DIALYZER, RINSE FLUID TESTED WITH FAST FORMALERT, RESULTS NEGATIVE. PT EXPERIENCED REACTION IMMEDIATELY. BLOOD SPEC ANALYSIS WAS POSITIVE FOR FORMALDEHYDE. REST OF CASE USED WITHOUT INCIDENT. POSSIBLE OPERATOR ERROR IN READING RESULTS.

Remedial action

  • Other