Model Number CSE-P-225-JA |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The complaint investigation of the returned bowl from the cell saver® elite set - 125ml confirmed a crack in the inner core base.Although there was no injury or harm to the patient, 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 death according to the surgeon that performed the surgery.Haemonetics decided to conservatively report inner core cracks that are confirmed by manufacturing due to the event of the past report.
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Event Description
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On april 20, 2023, haemonetics was notified that a "long hour returning error appeared" during a procedure in japan while utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 125ml.There was no reported impact to patient.
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Search Alerts/Recalls
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