BAXTER HEALTHCARE CORPORATION PRISMAXPRISMAX SYSTEM; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 955626 |
Device Problems
Defective Alarm (1014); Product Quality Problem (1506); Use of Device Problem (1670); No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2021 |
Event Type
malfunction
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Event Description
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Baxter prismax continuous renal replacement therapy (crrt) system began alarming "return disconnection." patient was assessed, lines were not disconnected, flow path was not obstructed, and fluid lines were not clamped.Lines were reversed at this time.Prismax crrt system continued to alarm.Machine was also alarming for high filter pressures.Filter pressures had not been previously elevated.Per prismax system, blood was unable to be returned.After machine was stripped and prior to shut down, an error stating "preventative maintenance is overdue." work order was entered at this time and machine was removed from rotation.Manufacturer response for baxter prismax crrt machine, prismax (per site reporter) mayo clinic in arizona 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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Baxter prismax continuous renal replacement therapy (crrt) system began alarming "return disconnection." patient was assessed, lines were not disconnected, flow path was not obstructed, and fluid lines were not clamped.Lines were reversed at this time.Prismax crrt system continued to alarm.Machine was also alarming for high filter pressures.Filter pressures had not been previously elevated.Per prismax system, blood was unable to be returned.After machine was stripped and prior to shut down, an error stating "preventative maintenance is overdue." work order was entered at this time and machine was removed from rotation.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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Baxter prismax continuous renal replacement therapy (crrt) system began alarming "return disconnection." patient was assessed, lines were not disconnected, flow path was not obstructed, and fluid lines were not clamped.Lines were reversed at this time.Prismax crrt system continued to alarm.Machine was also alarming for high filter pressures.Filter pressures had not been previously elevated.Per prismax system, blood was unable to be returned.After machine was stripped and prior to shut down, an error stating "preventative maintenance is overdue." work order was entered at this time and machine was removed from rotation.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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Search Alerts/Recalls
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