FDA Adverse Event Summary report: N

MEDI THERMIII

MDR report key: 2045025 · Received March 22, 2011

Report

Report Number
2045025
Date Received
March 22, 2011
Report Date
March 22, 2011
Manufacturer
GAYMAR INDUSTRIES
Product Code
DWJ
Report Source
User Facility report
Reporter Location
PA, US

Narratives

Description of Event or Problem · 1

THE EVENT OCCURRED WHEN THE NURSE COULD NOT GET A CONSTANT SET TEMPERATURE FOR THE PATIENT, CAUSING THE (ALERT ON) TO COME ON. MANY BLANKETS WERE REPLACED, BUT THE ALARM CONTINUED. AT ONE POINT THE NURSE TAPED THE CONNECTOR IN PLACE CAUSING INTERMITTENT ERRORS. SEEING THAT PROBLEM WAS INTERRUPTING THE PROCEDURE, WE SWITCHED THE UNIT WITH A SPARE. THE SPARE IS AN OLDER MODEL OF THE SAME UNIT, THE MTA 5942. THE NEWER MODEL MTA6900 DID NOT WORK WITH THE BLANKETS THAT THE HOSPITAL HAD IN STOCK. THE BLANKETS IN QUESTION WERE CINN. SUB ZERO MAXI-THERM LITE ADULT CATEGORY NUMBER 876, LOT NUMBER 760081. I WENT ONLINE TO RESEARCH THINKING THAT THE PROBLEM COULD BE THE BLANKETS. ACCORDING TO THE WEBSITE, THE BLANKETS WERE FINE. THE PROBLEM WAS THE CONNECTORS. THE MEDITHERM II AND MEDITHERM III HAD DIFFERENT STYLE CONNECTORS TO CONNECT THE BLANKETS. THE CONNECTORS ON THE UNITS THEMSELVES WERE FINE. AFTER INVESTIGATING I REALIZED THAT THE CONNECTOR FITS INTO THE BLANKET, BUT DOES NOT SNAP IN PLACE. BECAUSE THIS PROCEDURE REQUIRES A PRESCRIBED TEMPERATURE AT A PRESCRIBED TIME, FAILURE OF THAT WILL CAUSE DELAY, SERIOUS INJURY OR DEATH. THE PATIENT IS FINE, BUT THIS COULD HAVE BEEN WORSE IF IT WAS IGNORED. ALL NEW MODELS WERE REMOVED UNTIL THE HOSES WERE REPLACED WITH NEW HOSES SENT FROM THE MANUFACTURER. THIS CALLS FOR EVERYONE, NURSES, AND BIOMED TO PAY ATTENTION TO ANYTHING ESPECIALLY IF THE DEVICE SEEMS THE SAME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDI THERMIII HYPER/ HYPOTHERMIA MACHINE DWJ GAYMAR INDUSTRIES MTA6900 *

Patients

Seq Age Sex Outcome Treatment
1 *