On october 16, 2020 haemonetics manufacturing visually inspected the returned cell saver elite bowl, and confirmed there was blood in the inner core with one (1) crack, which resulted in the error the customer received.Although there was no serious injury or harm, past reporting (1219343-2020-00001-01) indicates this particular malfunction on a similar device has been associated with a reported death event.The investigation of 1219343-2020-00001-01 indicated the inner core of the bowl malfunctioned via a crack, but did not cause, or contribute to the reported incident according to the surgeon that performed the surgery.Haemonetics decided to conservatively report inner core cracks that are confirmed by manufacturing due the event of the past report.
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On september 24 2020 haemonetics was notified of a long hour returning message, which was displayed on the 7th cycle of the empty process during a spinal fusion procedure in (b)(6), utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 125ml.A total blood volume of 1600ml was processed, and there was no reported impact to patients' health.
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