LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 16-02-82 |
Device Problems
Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Post Operative Wound Infection (2446)
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Event Date 08/20/2017 |
Event Type
Injury
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Manufacturer Narrative
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Patient information was not provided.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in new (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Through follow-up communication with the customer livanova (b)(4) learned 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, or if the reported surgery is linked to the device in any way.The customer reported that no further information will be provided regarding this incident until the internal investigation is completed.Through follow-up communication with the customer, livanova (b)(4) learned that the device has been tested.However, the results of the testing have not yet been provided.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
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Event Description
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On september 22, 2017, livanova (b)(4) received a user medwatch report (mw5071897) which states that a patient became infected with mycobacterium abscessus and developed a sternal wound infection.The report indicated that the sternal wound infections identified at the facility are suspected to be related to the use of the heater-cooler device.However, at the time the user report was filed, a correlation had not yet been confirmed by the facility.On september 13, 2017, an article was identified in the advocate (http://www.Theadvocate.Com/new_orleans/news/article_4c2018e6-9714-11e7-8625-1bbf1c3f1683.Html) which identified 12 patients reportedly infected with mycobacterium abscessus.The article states that the patient was hospitalized due to the infection.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.However, the article did not explicitly state that mycobacterium abscessus has been identified in the device.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.
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Manufacturer Narrative
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Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.During follow-up communication on (b)(6) 2017, the customer provided an additional user medwatch report, which reported 11 patients.The report alleged that samples were taken from the involved device on (b)(6) 2017, and the samples tested positive for mycobacterium abscessus.
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Manufacturer Narrative
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Patient identifier: (b)(6).The user report stated that the date of therapy was (b)(6) 2017, and that the original surgery was an atriai septal defect repair.The medwatch report stated that wound cultures obtained on (b)(6) 2017, livanova (b)(4) received an updated medwatch report from fda relating to this case (mw5071897).
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Search Alerts/Recalls
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