SORIN GROUP DEUTSCHLAND SORIN 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
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/02/2016 |
Event Type
No Answer Provided
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Manufacturer Narrative
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Sorin implemented a field safety notice for disinfection and cleaning of sorin heater-cooler devices.The z number is z-2076/2081-2015.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).Sorin group (b)(4) manufactures the sorin heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Through follow-up communication, sorin group deutschland learned that the customer does not have the full test results available at this time, and the decision to return the devices for deep disinfection will not be made until the exact species of mycobaterium has been identified.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
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Event Description
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Sorin group (b)(4) received a report that the sorin heater-cooler system 3t tested positive for mycobacterium contamination.There is no known patient involvement.
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Manufacturer Narrative
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A livanova field service representative was dispatched to the facility to investigate.The unit was disassembled and visual inspection confirmed the reported issue.Photos of the device were taken and the unit was reassembled, fully drained and left empty.Through follow-up communication, livanova (b)(4) learned that the unit was confirmed to be contaminated with mycobacterium fortuitum on (b)(6) 2016 (sample taken in (b)(6) 2016).It was also reported that subsequent samples taken on (b)(6) 2017 were negative for contamination.A root cause was not determined.However, livanova (b)(4) has determined the most likely root causes to be failure to follow the cleaning and disinfection procedure outlined in the instructions for use (ifu), or cross-contamination.Eval'd on site; resolved by customer.
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