BAXTER HEALTHCARE CORPORATION PRISMAX CRRT MACHINE/BAXTER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Device Problem
Defective Device (2588)
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Patient Problems
Vascular System (Circulation), Impaired (2572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/23/2020 |
Event Type
Injury
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Event Description
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On (b)(6) 2020.Delay in our ability to provide life-saving treatment of crrt contributed to continued decompensation of physiologic and hemodynamic stability, and worsening acid-base balance in this patient.A temporary hd catheter was placed at approx.(b)(6) at 2350.Crrt was to be initiated immediately to treat acute renal failure.Both prismax crrt machines, our machine and a baxter loaner machine displayed alarm "b1215 arps system failed".This alarm is a red alarm and would not allow for priming of the set and treatment could not be started.Both machines were turned off and attempts to reload the filter cartridge were made multiple times with the same alarm.I also attempted to use the manual tool on the back to override the alarm.Baxter icon line was called to determine if issue could be remedied.Baxter rep insisted that both machines be removed from service as this alarm signaled that an internal hardware issue was present.I requested that a stat service ticket be placed and stressed the importance of treatment for this patient.I requested that the loaner department be emergently paged to determine if an alternate machine could be delivered.The loaner department was unable to provide a loaner and stated that none were immediately available in the dfw area.Fda safety report id # (b)(4).
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