Model Number CSE-P-225-JA |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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On june 02, 2021 haemonetics manufacturing performed a visual inspection of the received bowl from the cell saver® elite set - 225ml and confirmed bowl inner core leak.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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Event Description
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On june 01, 2021 haemonetics was notified of a leak found from the upper part of bowl into the centrifuge which was observed at 1st cycle filling during a coronary artery bypass procedure in (b)(6), utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 225ml.There was no reported impact to patients' health.
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Search Alerts/Recalls
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