translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Recall / Field Safety Notice

mdprc 086 03 17 001

2017-05-18

Saudi Arabia

SFDA

https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11073

Heater-cooler devices known or suspected to be contaminated with m. chimaera, based on the facility’s testing program or other information known to the hospital, should be removed from the operating room or, if feasible, from service as soon as is practicable. we recommend contacting your livanova representative to assess cleaning options prior to further use. 2. for facilities who have devices that are not known to be contaminated with m. chimaera, we recommend the following actions: following the operating instructions for heater-cooler devices and specifically those relating to cleaning and disinfecting. we continue to believe that following these operating instructions is essential to mitigating the potential risk posed by using these non-sterile devices. b. if appropriate for your operating room, direct or channel the heater-cooler exhaust away from the patient, e.G., to the operating room exhaust vent per the field safety notice “cardiac surgery mycobacterium risks c. conducting water quality monitoring per the field safety notice “cardiac surgery mycobacterium risks. d. using new accessories, tubing, and connectors to prevent recontamination when using a different heater-cooler device. be aware that device contamination also may occur from other sources such as environmental contamination or device contact with contaminated accessories.