inforMED
MalfunctionMLW

THERMOCHEM

Received Sep 1, 2009 · Event occurred Aug 17, 2009

Report 1478197 · MDR key 1478197

Device

Generic name

Intraperitoneal Hyperthermia System

Manufacturer

Thermasolutions

Model number

HT-1000

Catalog number

*

Lot number

*

Product problems

  • No Display/Image

Patient

60 YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THERMOCARE MACHINE WAS BEING USED WITH A HIPEC (HEATED INTRAOPERATIVE INTRAPERITONEAL CHEMOTHERAPY) CASE. THE PERFUSIONIST SAID THE SCREEN FROZE. TEMPERATURE REGULATION VIA THE MACHINE WAS DISABLED AND MANUAL TEMPERATURE REGULATION MEASURES WERE USED TO PROCEED WITH THE CASE. THERE WAS NO EFFECT/INJURY TO THE PATIENT. OUR BIOMED DEPARTMENT DID NOT ASSESS THE DEVICE AS IT WAS RETURNED TO THE MANUFACTURER'S REPRESENTATIVE IMMEDIATELY AFTER THE CASE. (THIS IS NOT OUR PROCEDURE AND THAT HAS BEEN ADDRESSED AT OUR LEVEL). BIOMED REPORTS THAT THIS IS THE THIRD TIME IN FOUR CASES THAT WE HAVE HAD PROBLEMS WITH AN HT-1000 FROM THERMASOLUTIONS. ALL THE OCCURRENCES INDICATE SCREEN ISSUES. HOWEVER, THERE ARE NO OTHER SIMILAR DEVICES AVAILABLE PER BIOMED DEPARTMENT.