* HT 1000R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-15 for * HT 1000R manufactured by Thermasolutions.

Event Text Entries

[2443407] While providing hyperthermic intraperitoneal chemotherapy (hipec), the thermachem machine had an electrical failure. After restarting the machine, i was able to resume the treatment after approximately thirty seconds. At this time medical engineering was paged to the room. After approximately a minute and a half the machine failed again. I restarted the machine again and continued with the treatment. Medical engineering had arrived and removed the side panel of the machine and while on the phone with a thermasolutions representative attempted to do a running repair of the machine. While the medical engineering personnel was doing the repair, the machine failed for a third time and i repeated what i had done before. After the machine was restarted, the medical engineer finished with the running repair and the machine had no further shutdowns. The medical engineer remained in the room for the remainder of the treatment delivery. Although i do not believe we were able to deliver an optimum treatment, it was near optimum and there was no harm done to the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2366914
• MDR Report Key: 2366914
• Date Received: 2011-11-15
• Date of Report: 2011-11-15
• Date of Event: 2011-11-10
• Report Date: 2011-11-15
• Date Reported to FDA: 2011-11-15
• Date Added to Maude: 2011-12-12
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: THERMOCHEM HT1000R
• Product Code: MLW
• Date Received: 2011-11-15
• Model Number: HT 1000R
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: THERMASOLUTIONS
• Manufacturer Address: 1889 BUERKLE ROAD BIRCHWOOD MN 55110 US 55110

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-11-15