Model Number CSE-P-125-JA |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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On november 26, 2020 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 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 november 10, 2020 haemonetics was notified of a returning error alarm which was displayed on the 7th cycle of the empty phase during a cardiac procedure in (b)(6), utilizing the cell saver¿ elite¿ autotransfusion system and cell saver¿ elite set - 125ml.There was no reported impact to patients' health.
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Search Alerts/Recalls
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