HAEMONETICS CORPORATION CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM; LOW VOL(125ML) CS5 SET,LN 261J
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Model Number 0261J-00 |
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 11/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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On november 17, 2020 haemonetics manufacturing performed a visual inspection of the received bowl from the low vol(125ml) cs5 set 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 ((b)(4) ) indicates this particular malfunction on a similar device has been associated with a reported death event.The investigation of (b)(4) 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 04, 2020 haemonetics was notified of a returning error alarm which was displayed on the empty phase during a procedure in (b)(6) , utilizing the cell saver 5 autologous blood recovery system and low vol(125ml) cs5 set.There was no reported impact to patients' health.
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Search Alerts/Recalls
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