Model Number CSE-P-125-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 Type
malfunction
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Manufacturer Narrative
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Haemonetics manufacturing performed a visual inspection of the received bowl from the cell saver® elite set - 125ml and confirmed blood in the inner core with a crack in the inner core base.Although there was no serious injury or patient 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 to the event of the past report.
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Event Description
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On november 19, 2021, haemonetics was notified of a long hour returning error that appeared about four hours after the start of the operation in (b)(6) utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 125ml.There was no reported impact to the health of the patient.
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Search Alerts/Recalls
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