BAXTER HEALTHCARE CORPORATION PRISMAXPRISMAX SYSTEM; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 955626 |
Device Problems
Computer Software Problem (1112); Product Quality Problem (1506); Unexpected Shutdown (4019); Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/14/2021 |
Event Type
malfunction
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Event Description
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Just after initiating a continuous renal replacement therapy (crrt), the prismax system alarmed air in blood and the process was followed to remove the air.The circuit began running again and then began alarming with the message, "system failure, contact support." registered nurse (rn) attempted to start the return blood process when the screen on the machine went completely black and turned off.The hd cath lines were clamped to the patient immediately.When the prismax machine came back on, the only option available was to discard the set and blood was unable to be returned to the patient.Patient remained hemodynamically stable with no increase in pressor requirements.A new filter was set up and crrt was reinitiated on the patient with no complications.Manufacturer response for baxter prismax crrt machine, prismax (per site reporter).(b)(6) in (b)(6) has been working closely with baxter including multiple site visits for over two and a half years in an attempt to identify the problems and fix the problems.
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Event Description
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Just after initiating a continuous renal replacement therapy (crrt), the prismax system alarmed air in blood and the process was followed to remove the air.The circuit began running again and then began alarming with the message, "system failure, contact support." registered nurse (rn) attempted to start the return blood process when the screen on the machine went completely black and turned off.The hd cath lines were clamped to the patient immediately.When the prismax machine came back on, the only option available was to discard the set and blood was unable to be returned to the patient.Patient remained hemodynamically stable with no increase in pressor requirements.A new filter was set up and crrt was reinitiated on the patient with no complications.Manufacturer response for baxter prismax crrt machine, prismax (per site reporter).User facility has been working closely with baxter including multiple site visits for over two and a half years in an attempt to identify the problems and fix the problems.
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Event Description
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Just after initiating a continuous renal replacement therapy (crrt), the prismax system alarmed air in blood and the process was followed to remove the air.The circuit began running again and then began alarming with the message, "system failure, contact support." registered nurse (rn) attempted to start the return blood process when the screen on the machine went completely black and turned off.The hd cath lines were clamped to the patient immediately.When the prismax machine came back on, the only option available was to discard the set and blood was unable to be returned to the patient.Patient remained hemodynamically stable with no increase in pressor requirements.A new filter was set up and crrt was reinitiated on the patient with no complications.Manufacturer response for baxter prismax crrt machine, prismax (per site reporter).User facility has been working closely with baxter including multiple site visits for over two and a half years in an attempt to identify the problems and fix the problems.
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