WebThe FDA has warned that bacterial infections have been linked to heater cooler units used throughout the country. The Mycobacterium chimaera is insidious, multiplying and spreading slowly over months and even years. ... Cincinnati Sub-Zero 333W and Hemotherm; Terumo HX2; Medical Device Reports (MDRs) are submitted to the FDA when a device is ... WebBetween January 2010 and August 2015, the FDA received 32 Medical Device Reports (MDRs) of patient infections resulting from contaminated heater-cooler devices used during various open-heart or open-chest surgical procedures. The FDA received a total … Drugwatch.com has provided reliable, trusted information about medications, …
K<(gI - Food and Drug Administration
WebCincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528 Manufacturer Parent Company (2024) Gentherm, Inc. Source USFDA 14 Events ... Hemotherm 48¿C Dual Reservoir Heater/Cooler System, Model Number: 400 and Model Number: 400MR. The 48 o ( Degree) C Hemotherm Dual Reservoir Heater/Cooler I … WebCincinnati Sub-Zero c/o Mr. Steven J. Berke President and CEO 12011 Mosteller Road Cincinnati, OH 45241-1528 Re: K122813 Hemnotherm®g Model 400CE Dual Reservoir Cooler/Heater System Regulation Number: 21 CFR 870.4250 Regulation Name: Controller, Temperature, Cardiopulmonary Bypass Regulatory Class: Class 11 Product Code: DWC philips 805 oder 806
An Update on Mycobacterium chimaera and Cardiac Surgery Infections …
WebDUAL RESERVOIR COOLER/HEATER MODEL 400MR OPERATION & TECHNICAL MANUAL Cincinnati Sub-Zero Products, Inc. • 12011 Mosteller Road • Cincinnati, Ohio … WebCDC has warned hospitals and patients about the potential risk of Nontuberculous Mycobacteria (NTM) infections from certain heater-cooler devices used during open heart (open-chest) surgery. Patients who have … WebMar 27, 2024 · HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM: Applicant: CINCINNATI SUB-ZERO PRODUCTS, INC. 12011 MOSTELLER RD. CINCINNATI, OH … philips 8049/01