OUTSET MEDICAL, INC. TABLO CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Model Number PN-0005643 |
Device Problems
Defective Alarm (1014); Fluid/Blood Leak (1250); Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/19/2022 |
Event Type
malfunction
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Event Description
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Nearing end of sled (sustained low-efficiency dialysis) treatment, top portion of sled dialyzer leaked.Approx 400cc blood into the floor.Sled did not alarm.Lure lock was checked and secure, treatment resumed and flush started.Treatment continued for 10 minutes before the tmp became too high and forced to stop the treatment and return blood 30 minutes early.Pt had been given heparin bolus via sled for this treatment.Pt has been on sled multiple times now and the filter has clogged/clotted multiple times per treatment.Fda safety report id# (b)(4).
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