OUTSET MEDICAL, INC. TABLO CARTIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Model Number PN-0004220 |
Device Problems
Fluid/Blood Leak (1250); Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2022 |
Event Type
malfunction
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Event Description
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Seven and a half (7.5) hours into sled(sustained low-efficiency dialysis), dialysis, rn noted clots in the filter and the high pressure alarm sounded just prior to the dialyzer leaking blood at the top.Leak caught quickly - blood was not able to be returned.D2200604 lot cartridge removed and rn attempted to start 2nd treatment, machine would not allow.Another machine was obtained and treatment started and completed successfully.A delay of 1.75 hours occurred between the leak and getting the new equipment started.The rn involved has sled competencies and had done multiple sled procedures successfully prior to this incident.No patient injury was noted.
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