HAEMONETICS CORPORATION CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM; CS ELITE FASTPACK,125ML,150U
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Model Number CSE-FP-125V |
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 12/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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On december 08, 2021 haemonetics manufacturing performed a visual inspection of the received bowl from the cell saver® elite fastpack - 125ml and confirmed blood in the inner core with cracks 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 december 08, 2021, haemonetics was notified of a fractured latham bowl and leaked blood in the inner cavity during a procedure in (b)(6), utilizing the cell saver® elite® autotransfusion system and cell saver® elite fastpack - 125ml.There was no reported impact to patients' health.
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Search Alerts/Recalls
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