LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 16-02-80 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
Death (1802)
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Event Date 04/07/2012 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was provided partially.Through follow up communication, livanova (b)(4) learned, that patients weight in 2012 was (b)(6) kg, which reduced to (b)(6) kg in 2015.Patients size was 166 cm in 2012 and 162 cm in 2015.Serial number is unknown.This information will be provided in a supplemental report if made available.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if information made available.Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.(b)(6) livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Through follow up communication, livanova (b)(4) learned that there are two possibly affected heater-cooler system 3t with the serial numbers (b)(4).Further analysis revealed that the manufacturing date of these devices is subsequent to the date of the surgery.Through additional further communication, livanova (b)(4) learned, about three (3) further serial numbers that could possibly have been involved in the event in the year 2012.A review of the dhr for all serial numbers could not identify any deviations or nonconformities relevant to the issue.Based on the information livanova collected it can be assumed that the heater-cooler system 3ts may not have been cleaned as recommended by ifu in the past.Through further communication, livanova (b)(4) learned, that since (b)(6) 2018 the heater-cooler system 3ts are cleaned according to the instruction for use.A laboratory test, which stated positivity for mycobacterium intracellulare has been provided to livanova (b)(4) and is dated (b)(6) 2015.Investigation on this type of infection is on-going.The investigation is ongoing.Corrective actions are in progress for this issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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Livanova (b)(4) received a formal letter from cci (compensation commission for medical accidents and nosocomial infections), that a patient with the initials (b)(6), born on (b)(6), was tested positive on mycobacterium chimaera, deceased on (b)(6) 2018.Within the report it is stated, that the patient underwent an ascending aorta replacement and arch repair in 2012, sees a cardiologist because of medical background and pain in (b)(6) 2013, is hospitalized in (b)(6) 2013 due to fever, pain, epigastric pain, emaciation, weakness and established in (b)(6) 2013 aortic implant infection.General condition decreases until (b)(6) 2014, hepatic, pancreatic, ocular and cerebral diseases are confirmed along with mycobacterium chimaera.Therapy started in (b)(6) 2014 as well as dialysis three times a week.Patient underwent an infected implant replacement in (b)(6) 2015 and in (b)(6) 2015 his spine had to be repaired and patient had to wear a corset afterwards.In (b)(6) 2016 a fistula is installed as veins are damaged because of multiple blood testing.In (b)(6) 2018 patients health continues to decrease and is hospitalized in (b)(6) 2018 (also followed in (b)(6) ) being diagnosed with emerging highly resistant bacterium at the anus.
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Manufacturer Narrative
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Livanova deutschland investigation revealed that demineralized water was used instead of decalcified water at the time of the surgery.
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Event Description
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See initial report.
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Event Description
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See initial report.
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Manufacturer Narrative
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H.10: the information provided (livanova deutschland investigation revealed that demineralized water was used instead of decalcified water at the time of the surgery.) in the previous follow up report is not correct.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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See initial report.
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Manufacturer Narrative
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H.10: a document edited in 2014 regarding the maintenance practice followed by the hospital, has been shared with livanova deutschland.In the document it is stated that the practice was not conducted as per the instruction for use.Moreover, through further follow up communication livanova deutschland learned that the serial number used for the surgery was (b)(6) (device information has been added to the dedicated section d.4).No evidence of contaminated device has been provided.
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