Model Number CSE-P-225-JA |
Device Problem
Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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No patient information was provided at this time.The bowl from the cell saver elite set was returned and evaluated by haemonetics.It was noted during investigation that cracks existed at the circumference of the base rim of the bowl, blood leakage was confirmed.Bowl airtightness testing confirmed air leakage and water running test confirmed leakage from the base rim cracks in the bowl.
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Event Description
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On (b)(6) 2020 haemonetics was notified of a fluid eruption which had occurred during a spinal procedure, utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 225ml.There was no reported impact to patients' health and no possible exposure to the techs involved in cleaning the system.
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Search Alerts/Recalls
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