OUTSET MEDICAL, INC. TABLO CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Model Number PN-0005643 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/26/2022 |
Event Type
malfunction
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Event Description
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Sled: complete disconnection between red (access line) and the dialyzer/filter.Blood dripping onto floor.Access alarms.Fda safety report id# (b)(4).
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Search Alerts/Recalls
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