Catalog Number 2C8750 |
Device Problems
Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The date of the event was reported as an unknown date in (b)(6) 2020.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that a clearlink system y-type blood/solution set leaked.It was further reported "the blood product tubing leaked at the bottom of the filter chamber.The outer plastic ring was not sealed".The device was filled with blood platelets.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Correction: f2 and g3.F2: the user facility submitted a medwatch report for this event: 2400100000-2020-8028.G3: remove consumer (from follow up # 1) and replace with user facility.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Additional information was added to h6.H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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