Pt weight: (b)(6) kg.Recall number; livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).During a literature search conducted on september 14, 2017, livanova (b)(4) identified an article from the advocate (http://www.Theadvocate.Com/new_orleans/news/article_4c2018e6-9714-11e7-8625-1bbf1c3f1683.Html) which stated that the facility was allegedly able to trace the source to a single operating room and a single device which the facility believes caused the issue.The article reported that the suspected device has been replaced and ongoing environmental surveillance of the operating rooms has not shown any contamination with the organism beyond the involved device.During follow-up communication, the facility reported that the devices have been cultured regularly and have tested positive for contamination in the past.However, it was also reported that they have been able to get them clean.It is unknown if the device(s) was contaminated at the time of surgery.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
|
On (b)(6) 2017, livanova (b)(4) received 13 user medwatch reports detailing 11 patients with confirmed mycobacterium abscessus sternal wound infections and 2 patients with suspected mycobacterium abscessus infections, which were reportedly contracted following cardiothoracic surgeries that utlized the heater-cooler system 3t.Separate reports have already been submitted for the 11 confirmed cases and 1 of the suspected cases (see medwatch reports 9611109-2017-00691, 9611109-2017-00692, 9611109-2017-00693, 9611109-2017-00694, 9611109-2017-00789, 9611109-2017-00790, 9611109-2017-00791, 9611109-2017-00792, 9611109-2017-00793, 9611109-2017-00794, and 9611109-2017-00795 for the confirmed cases and 9611109-2017-00788 for the suspected case).This report is being filed in regards to the second suspected case.The user report stated that the date of therapy was (b)(6) 2017 and that the original surgery was completion of a fontan procedure.The medwatch report stated that no wound cultures obtained were positive for mycobacterium abscessus.However, the hospital suspects the patient is infected and has treated the patient accordingly.The report also alleged that samples were taken from the involved device on (b)(6) 2017, and the samples tested positive for mycobacterium abscessus.On (b)(6) 2017, livanova (b)(4) received a medwatch report from fda relating to this case (mw5073833).
|