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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 045 02 18 000
Date submitted: 2/13/2018
Manufacturer:Medtronic
Device Type:Bio-Cal Temperature Controller
Description:Heart-lung bypass system module, temperature control unit
Medical Device Identifier:Model Number 370 and 370I
Reason of Field Safety Corrective Action:In recent years, safety issues have been raised by regulators, including FDA, regarding water system quality of temperature controllers, regardless of the manufacturer. The concern stems from the potential for bacterial growth in the water systems that can be transmitted to patients during surgery, and is likely related to the recommended water system cleaning practices and protocols employed. Medtronic distributed BIO-CAL devices to the marketplace between 1989 and 2011. As of January 31, 2018, there have been two complaints received that suggest patients acquired a serious infection while undergoing surgery when a BIO-CAL device was being utilized. These complaints were received from a single customer in 2015. Although a direct causal connection between the patient infection and the BIO-CAL could not be confirmed, the infection type was consistent with a waterborne bacterium (Mycobacterium abcessus) and could have been attributed to the site’s cleaning and disinfecting of the device prior to use.
Remedy Action:• Medtronic is recommending that BIO-CAL Temperature Controllers Models 370 and 370I are no longer used for clinical procedures. An updated cleaning protocol will not be developed by Medtronic.
• Dispose of any devices in your possession per your normal equipment obsolescence procedures. Do not resell for clinical use.
• For patients who were exposed to a BIO-CAL device, there are no recommendations for additional follow-up, physician communication, or a change in patient management beyond routine practice. If infection and/or symptoms do develop after patients were exposed to a BIO-CAL device, health care professionals should refer to:
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/)
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:A9D25EECA2367
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf