inforMED
MalfunctionLHC

THERMABASIN

Received Feb 8, 2017 · Event occurred Feb 8, 2017

Report MW5067794 · MDR key 6321667

Device

Generic name

Warmer Irrigation

Manufacturer

Ecolab/microtek

Model number

REF:ITB100

Catalog number

ITB100

Lot number

76245

Product problems

  • Device Contamination with Chemical or Other Material

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

SETTING UP STERILE FIELD FOR SURGERY AND NOTED APPROXIMATELY 1/8" PIECE OF LIGHT BLUE PLASTIC (APPROXIMATE DIAMETER OF A STANDARD STAPLE) INSIDE THE BASIN. PROCEDURE HAD NOT STARTED YET AND THIS DID NOT AFFECT THE PT. HOWEVER, SOLUTIONS LATER POURED INTO THE BASIS ARE USED FOR IRRIGATING AND FOR INTRAVASCULAR INJECTION.