SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 16-02-85 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Death (1802)
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Event Date 03/29/2016 |
Event Type
Death
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Manufacturer Narrative
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Patient identifier was not disclosed.Patient weight was stated as unknown in the user report.The event date in the user medwatch report was listed as the date of the procedure ((b)(6) 2011).However, we have selected the event date to be the day when the patient presented with symptoms ((b)(6) 2916).The serial number of the involved device is unknown.This information will be provided in a supplemental report if and when made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if and when made available.(b)(4).Through follow-up communication with the customer, sorin group deutschland learned that the units in use at the facility at the time of the surgery have been tested.However, the test results have not been provided.The contact stated that the units are not tested on a regular basis.The customer reported that one new device has been obtained.However, all of the units are still in use and are operated within the or.Circumstances surrounding the patient's death are unknown at this time.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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On january 6, 2017, sorin group (b)(4) received a user medwatch report (b)(4) stating that a patient presented with symptoms of infection on (b)(6) 2016 after undergoing a coronary artery bypass grafting procedure on (b)(6) 2011 that included the use of a sorin heater-cooler system 3t.The symptoms included general malaise, weakness, fatigue and poor oral intake.Blood cultures were taken on (b)(6) 2016 and tested positive for mycobacterium avium complex.The report stated that additional testing of blood cultures is being conducted.The patient was reported to have expired 5 months after presenting with symptoms, on (b)(6) 2016.The exact cause of death was not reported.
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Search Alerts/Recalls
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