HAEMONETICS CORPORATION CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM; CS ELITE PROCESSING KIT, 125ML
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Model Number CSE-P-125 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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Haemonetics sent a field service engineer to evaluate the cell saver® elite® autotransfusion system in order to check for any faults, the machine was found to meet specifications and did not have any defects which required repair.The cell saver® elite set - 125ml sample was not returned to haemonetics.Customer stated that there were no visible cracks or leaks observed, without physical sample haemonetics is unable to confirm or determine root cause.
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Event Description
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On (b)(6) 2020 haemonetics was notified of a returning error alarm which was displayed during an emergency c section procedure in (b)(6), utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 125ml.Hameonetics was also notified of fluid coming up from the waste bag.Blood was discarded due to contamination concerns, there was a reported blood loss of 800ml.
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Search Alerts/Recalls
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