prisMaxPrisMax System 955626Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00085412639499), received between Mar 19, 2020 and Dec 19, 2025 — classified as 17 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (14 reports).

4 FDA recall records name this device's identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 28, 2025Class IIOpen, Classified

   Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles

   Z-2437-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Mar 15, 2022Class IIOpen, Classified

   This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function, the PrisMax System will return the patient Gain/Loss Limit or the RDL to the default value, rather than the non-default value entered at the initiation of treatment. The PrisMax System interface will display the original values once treatment is restarted but does not have an alert to inform the user of the change. The RDL value will be returned to the original value immediately upon selecting the Same Patient function. The Gain/Loss Limit value will be returned to the original value when the patient weight and/or hematocrit is changed during treatment.

   Z-0991-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Sep 29, 2021Class IIOpen, Classified

   If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.

   Z-0215-2022 · Root cause: Software design · Recall details · FDA record ↗

4. Jan 7, 2021Class IITerminated

   Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. This tubing is normally replaced during annual preventative maintenance. Alarm Situations: During System Self-Test: Alarm code B1215 (ARPS Self-Test failure); During Therapy: B1273 (ARPS Leak), B1215 (ARPS Pressure self-test), B1116 (Return Pressure self-test Failure), B1539 (Access Pod Reposition Failure), B1541 (Effluent Pod Reposition Failure), B1540 (Effluent Filter Pod Reposition Failure). If an alarm occurs, it may lead to delay or interruption of therapy. In the event that therapy is terminated without returning blood to the patient, blood loss may occur.

   Z-1151-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT A PEDIATRIC PATIENT WAS UNDERGOING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A PRISMAX MACHINE. IT WAS FURTHER REPORTED THAT THE CRRT SYSTEM WAS RUNNING WITH AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SYSTEM. ACCORDING TO THE REPORTER, THE MACHINE GENERATED "THE EXACT SAME ISSUE" WHICH WAS REPORTED AS "SYSTEM FAILURE ALARMS OVER A PERIOD OF A FEW DAYS" WHICH RESULTED IN TREATMENT BEING TERMINATED WITHOUT THE EXTRACORPOREAL (EC) BLOOD BEING RETURNED TO THE PATIENT. THE NURSE REPORTED THAT THE "MACHINES WOULD SUDDENLY SHUT DOWN BY THEMSELVES". IT WAS REPORTED THAT "THE STAFF WOULD TROUBLESHOOT AND TRY TO TURN IT ON AGAIN TO RESTART TREATMENT BUT NOT ABLE TO TURN IT ON OR NOT ABLE TO RESOLVE THE ALARM AND SO WOULD STOP THE TREATMENT". IT WAS REPORTED "THE STAFF DID NOT FEEL COMFORTABLE RETURNING THE BLOOD THE FOLLOWING REASONS: 1) STAFF WAS TROUBLE SHOOTING FOR ABOUT 10 MINUTES THEREFORE BLOOD COULD HAVE CLOTTED THEREFORE WOULD BE ABLE TO RETURN POSSIBLE CLOTTED BLOOD, 2) THE TREATMENT WAS RUNNING WITH ECMO AND STAFF DID NOT FEEL COMFORTABLE TO RETURN THE BLOOD SINCE IT WAS RUNNING WITH ECMO. THE MEDICAL PERSONNEL HAVE BEEN TRAINED ON THE MANUAL BLOOD

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23856053 ↗
• MalfunctionDec 19, 2025Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT A PEDIATRIC PATIENT WAS UNDERGOING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A PRISMAX MACHINE. IT WAS FURTHER REPORTED THAT THE CRRT SYSTEM WAS RUNNING WITH AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SYSTEM. ACCORDING TO THE REPORTER, THE MACHINE GENERATED "A CALL SERVICE ALARM". IT WAS REPORTED THAT THE ALARM WAS GENERATED "ABOUT 2-3 HOURS AFTER TREATMENT WAS STARTED". IT WAS REPORTED THAT A SECOND UNSPECIFIED ALARM WAS GENERATED APPROXIMATELY FOUR HOURS AND 15 MINUTES AFTER THE FIRST ALARM. THE NURSE REPORTED THAT THE "MACHINES WOULD SUDDENLY SHUT DOWN BY THEMSELVES". IT WAS REPORTED THAT "THE STAFF WOULD TROUBLESHOOT AND TRY TO TURN IT ON AGAIN TO RESTART TREATMENT BUT NOT ABLE TO TURN IT ON OR NOT ABLE TO RESOLVE THE ALARM AND SO WOULD STOP THE TREATMENT". THE STAFF DETERMINED TO RESTART TREATMENT WITH A NEW PRISMAX DEVICE TO CONTINUE THERAPY (TWO PRISMAX DEVICES WERE USED). IT WAS REPORTED "THE STAFF DID NOT FEEL COMFORTABLE RETURNING THE BLOOD THE FOLLOWING REASONS: 1) STAFF WAS TROUBLE SHOOTING FOR ABOUT 10 MINUTES THEREFORE BLOOD COULD HAVE CLOTTED THEREFORE WOULD BE ABLE TO RETURN POSSIBLE CLOTTED BLOOD, 2) THE TREATMENT WAS RUNNING WITH EC

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23854855 ↗
• MalfunctionDec 19, 2025Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT A PEDIATRIC PATIENT WAS UNDERGOING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A PRISMAX MACHINE. IT WAS FURTHER REPORTED THAT THE CRRT SYSTEM WAS RUNNING WITH AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SYSTEM. ACCORDING TO THE REPORTER, THE MACHINE GENERATED "A CALL SERVICE ALARM". IT WAS REPORTED THAT THE ALARM WAS GENERATED "ABOUT 2-3 HOURS AFTER TREATMENT WAS STARTED". IT WAS REPORTED THAT A SECOND UNSPECIFIED ALARM WAS GENERATED APPROXIMATELY FOUR HOURS AND 15 MINUTES AFTER THE FIRST ALARM. THE NURSE REPORTED THAT THE "MACHINES WOULD SUDDENLY SHUT DOWN BY THEMSELVES". IT WAS REPORTED THAT "THE STAFF WOULD TROUBLESHOOT AND TRY TO TURN IT ON AGAIN TO RESTART TREATMENT BUT NOT ABLE TO TURN IT ON OR NOT ABLE TO RESOLVE THE ALARM AND SO WOULD STOP THE TREATMENT". THE STAFF DETERMINED TO RESTART TREATMENT WITH A NEW PRISMAX DEVICE TO CONTINUE THERAPY (TWO PRISMAX DEVICES WERE USED). IT WAS REPORTED "THE STAFF DID NOT FEEL COMFORTABLE RETURNING THE BLOOD THE FOLLOWING REASONS: 1) STAFF WAS TROUBLE SHOOTING FOR ABOUT 10 MINUTES THEREFORE BLOOD COULD HAVE CLOTTED THEREFORE WOULD BE ABLE TO RETURN POSSIBLE CLOTTED BLOOD, 2) THE TREATMENT WAS RUNNING WITH

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23854831 ↗
• MalfunctionDec 19, 2025Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT A PEDIATRIC PATIENT WAS UNDERGOING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A PRISMAX MACHINE. IT WAS FURTHER REPORTED THAT THE CRRT SYSTEM WAS RUNNING WITH AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SYSTEM. ACCORDING TO THE REPORTER, THE MACHINE GENERATED THREE "SYSTEM FAILURE ALARMS" WHICH RESULTED IN TREATMENT BEING TERMINATED WITHOUT THE EXTRACORPOREAL (EC) BLOOD BEING RETURNED TO THE PATIENT. IT WAS REPORTED THAT THE FIRST ALARM WAS GENERATED "ABOUT 2-3 HOURS AFTER TREATMENT WAS STARTED". THE SECOND ALARM WAS GENERATED APPROXIMATELY TWO HOURS AFTER THE FIRST ALARM AND THE THIRD ALARM WAS GENERATED APPROXIMATELY SIX HOURS AFTER THE SECOND ALARM. THE NURSE REPORTED THAT THE "MACHINES WOULD SUDDENLY SHUT DOWN BY THEMSELVES". IT WAS REPORTED THAT "THE STAFF WOULD TROUBLESHOOT AND TRY TO TURN IT ON AGAIN TO RESTART TREATMENT BUT NOT ABLE TO TURN IT ON OR NOT ABLE TO RESOLVE THE ALARM AND SO WOULD STOP THE TREATMENT". THE STAFF DETERMINED TO RESTART TREATMENT WITH A NEW PRISMAX DEVICE TO CONTINUE THERAPY (THREE PRISMAX DEVICES WERE USED). IT WAS REPORTED "THE STAFF DID NOT FEEL COMFORTABLE RETURNING THE BLOOD THE FOLLOWING REASONS: 1) STAFF WAS TROUB

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23854774 ↗
• MalfunctionDec 19, 2025Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT A PEDIATRIC PATIENT WAS UNDERGOING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A PRISMAX MACHINE. IT WAS FURTHER REPORTED THAT THE CRRT SYSTEM WAS RUNNING WITH AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SYSTEM. ACCORDING TO THE REPORTER, THE MACHINE GENERATED THREE "SYSTEM FAILURE ALARMS" WHICH RESULTED IN TREATMENT BEING TERMINATED WITHOUT THE EXTRACORPOREAL (EC) BLOOD BEING RETURNED TO THE PATIENT. IT WAS REPORTED THAT THE FIRST ALARM WAS GENERATED "ABOUT 2-3 HOURS AFTER TREATMENT WAS STARTED". THE SECOND ALARM WAS GENERATED APPROXIMATELY TWO HOURS AFTER THE FIRST ALARM AND THE THIRD ALARM WAS GENERATED APPROXIMATELY SIX HOURS AFTER THE SECOND ALARM. THE NURSE REPORTED THAT THE "MACHINES WOULD SUDDENLY SHUT DOWN BY THEMSELVES". IT WAS REPORTED THAT "THE STAFF WOULD TROUBLESHOOT AND TRY TO TURN IT ON AGAIN TO RESTART TREATMENT BUT NOT ABLE TO TURN IT ON OR NOT ABLE TO RESOLVE THE ALARM AND SO WOULD STOP THE TREATMENT". THE STAFF DETERMINED TO RESTART TREATMENT WITH A NEW PRISMAX DEVICE TO CONTINUE THERAPY (THREE PRISMAX DEVICES WERE USED). IT WAS REPORTED "THE STAFF DID NOT FEEL COMFORTABLE RETURNING THE BLOOD THE FOLLOWING REASONS: 1) STAFF WAS TROUB

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23854773 ↗
• MalfunctionDec 1, 2025Filtration Problem; Filtration Problem

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAX MACHINE, AN ALARM RELATED TO ACCESS EXTREMELY NEGATIVE WAS OBSERVED. TREATMENT WAS DISCONTINUED AND THE EXTRACORPOREAL BLOOD WAS NOT RETURNED TO THE PATIENT. ADDITIONALLY REPORTED WAS THAT THE "PATIENT ALREADY HAD ONE FILTER SET CLOTTED". THE TOTAL VOLUME OF BLOOD LOSS WAS NOT KNOWN. THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682458 ↗
• InjuryOct 31, 2025Filling Problem; Filling Problem

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY USING A PRISMAX MACHINE, "AN ENTIRE SYRINGE OF HEPARIN¿ (14 MLS) WAS ADMINISTERED TO THE PATIENT "WITHOUT NURSING INSTRUCTION". THE REPORTER STATED THAT A 20-CC SYRINGE WAS USED. ACCORDING TO THE REPORTER, THE PATIENT¿S PARTIAL THROMBOPLASTIN TIME INCREASED AND THE HEMOGLOBIN DROPPED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, SHORTNESS OF BREATH AND FLUID OVERLOAD. THE PATIENT RECEIVED ONE UNIT OF BLOOD DUE TO DECREASED HEMOGLOBIN LEVELS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Anemia; Dyspnea; Swelling/ Edema

  MAUDE report 23439126 ↗
• MalfunctionSep 2, 2025Device Alarm System; False Alarm; Inflation Problem

  THE PRISMAX MACHINES EXPERIENCED MULTIPLE ISSUES, INCLUDING VARIOUS ALARMS, FILTER SET FAILURES, AND THERMAX "FAILURE TO INFLATE" ERRORS. DESPITE ATTEMPTS TO PRIME THE MACHINES, THE PROCESS COULD NOT BE COMPLETED DUE TO AIR IN THE LINE, EVEN THOUGH NO AIR WAS ACTUALLY PRESENT. THESE PROBLEMS RESULTED IN A DELAY OF CARE BY 2-3 HOURS.

  Patient problems: Insufficient Information

  MAUDE report 22929755 ↗
• MalfunctionAug 6, 2025Display or Visual Feedback Problem; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  PT WAS ORDERED FOR CVVH [CONTINUOUS VENO-VENOUS HEMOFILTRATION] ON [DATE REDACTED] DUE TO SOFT BPS [BLOOD PRESSURE] AND CONCERNING INFECTION TO HD [HEMODIALYSIS] SITE. MACHINE SET-UP AND PRIMING, WHICH TAKES NEARLY AN HOUR, RESULTED WITH ERROR MESSAGING READING, B2084, "A SYSTEM FAILURE HAS OCCURRED. WARNING: DISCONTINUE TREATMENT." THE NEXT MACHINE WAS ATTEMPTED FOR USE WHICH TOOK ANOTHER HOUR TO SET UP IN PT'S ROOM. THE NEXT MACHINE ALSO GAVE ERROR MESSAGES CREATING A FURTHER DELAY AND NEED FOR GATHERING MORE SUPPLIES AND A CHANGE OF MACHINERY ONCE AGAIN. THE PATIENT'S CVVH WAS DELAYED MULTIPLE HOURS DUE TO FAULTY MACHINES.

  Patient problems: Low Blood Pressure/ Hypotension; Unspecified Infection

  MAUDE report 22728230 ↗
• MalfunctionNov 21, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A PRISMAX MACHINE, A PATIENT EXPERIENCED A ¿BRAIN AIR EMBOLISM". SUBSEQUENTLY, THE PATIENT PASSED AWAY. THE REPORTER STATED THE PATIENT "EXPIRED OF A BRAIN AIR EMBOLISM". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Air Embolism

  MAUDE report 20750148 ↗
• InjuryAug 29, 2023Protective Measures Problem; Unexpected Shutdown; Protective Measures Problem; Unexpected Shutdown

  IT WAS REPORTED THAT, DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAX MACHINE, THE MACHINE "ENDED TREATMENT WITH CALL SERVICE POWERING OFF SUDDENLY WITHOUT RESTARTING ITSELF". THE BEDSIDE NURSE REPORTED TREATMENT WAS ENDED WITHOUT THE EXTRACORPOREAL BLOOD BEING RETURNED TO THE PATIENT. IT WAS FURTHER REPORTED THE PATIENT RECEIVED A BLOOD TRANSFUSION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17641844 ↗
• InjuryJun 26, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A PATIENT WAS RECEIVING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A PRISMAX MACHINE. IT WAS FURTHER REPORTED THAT A LEFT SUBCLAVIAN CORDIS HAD JUST BEEN REMOVED AND THE NURSE WAS HOLDING PRESSURE OVER THE SITE WHEN THE PATIENT COUGHED WHICH GENERATED AN AIR DETECTED ALARM BY THE DEVICE. TROUBLESHOOTING OF THE AIR ALARM WAS PERFORMED. THE PATIENT EXPERIENCED LABORED BREATHING WITH A SATURATION OF 80S, AND THE SYSTOLIC BLOOD PRESSURE DROPPED TO 60MMHG WITH A HEART RATE OF 130 BEATS/MIN. IT WAS REPORTED A CODE BLUE WAS INITIATED. ACCORDING TO THE REPORTER AIR WAS REPORTEDLY SEEN IN BLUE RETURN LINE. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Decreased Respiratory Rate; Low Blood Pressure/ Hypotension

  MAUDE report 17198973 ↗
• MalfunctionApr 25, 2023Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED AN AIR DETECTION ALARM WAS TRIGGERED ON A PRISMAX MACHINE. DUE TO THE POTENTIAL FOR AIR BUBBLES, THE EXTRACORPOREAL BLOOD COULD NOT BE RETURNED TO THE PATIENT AT THE END OF THERAPEUTIC PLASMA EXCHANGE. THIS EVENT OCCURRED TWICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806711 ↗
• InjuryMar 21, 2023Break; Protective Measures Problem; Break; Protective Measures Problem

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY USING A PRISMAX MACHINE, WHILE ATTEMPTING TO CHANGE THE CIRCUIT, AN UNSPECIFIED ALARM WAS TRIGGERED, AND THE TREATMENT WAS TERMINATED. THE OPERATOR ATTEMPTED TO MANUALLY RETURN THE BLOOD; HOWEVER, DUE TO A BROKEN HAND CRANK ("THE SILVER PART CAME OUT OF THE BLACK PART"), THE EXTRACORPOREAL BLOOD COULD NOT BE RETURNED TO THE PATIENT. THE PATIENT REPORTEDLY REQUIRED ¿INCREASED EPI DRIP¿. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16584416 ↗
• MalfunctionJan 4, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY USING A PRISMAX MACHINE, THE PATIENT RECEIVED A HEPARIN BOLUS AS A RESULT OF THE SYRINGE EMPTIED COMPLETELY WHEN CHANGING THE SYRINGE. THE EVENT OCCURRED AFTER MULTIPLE ALARMS WERE GENERATED INCLUDING BAG EMPTY; ACCESS DISCONNECTION; EFFLUENT LINE CLAMPED; HEPARIN SYRINGE EMPTY. IT WAS FURTHER REPORTED THE NURSE ATTEMPTED TO REINSTALL THE SAME SYRINGE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095252 ↗
• MalfunctionJan 4, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY USING A PRISMAX MACHINE, THE PATIENT RECEIVED A HEPARIN BOLUS AS A RESULT OF THE SYRINGE EMPTIED COMPLETELY WHEN CHANGING THE SYRINGE. THE EVENT OCCURRED AFTER MULTIPLE ALARMS WERE GENERATED INCLUDING BAG EMPTY; ACCESS DISCONNECTION; EFFLUENT LINE CLAMPED; HEPARIN SYRINGE EMPTY . IT WAS FURTHER REPORTED THE NURSE ATTEMPTED TO REINSTALL THE SAME SYRINGE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095189 ↗
• InjuryDec 27, 2022Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A PRISMAX MACHINE, A PATIENT CODED AND A CHANGE SET ALARM WAS GENERATED BY THE DEVICE. THE EXTRACORPOREAL BLOOD WAS NOT RETURNED TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cardiac Arrest

  MAUDE report 16050254 ↗
• InjuryDec 20, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT "OVERHEATING" OF A PRISMAX MACHINE WAS OBSERVED AFTER BEING USED FOR EXTENDED PERIODS. IN ALL INSTANCES, EXTRACORPOREAL BLOOD WAS MANUALLY RETURNED TO THE PATIENT. BLOOD CLOTS WERE OBSERVED, AND THE PATIENTS WERE TRANSFUSED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16014344 ↗
• MalfunctionJul 28, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A PRISMAX CONTROL UNIT AND TWO UNITS OF A PRISMAFLEX SET, AN AIR IN BLOOD WAS OBSERVED. IT WAS NOT REPORTED IF AN ALARM WAS GENERATED BY THE PRISMAX CONTROL UNIT. THE TREATMENT WAS ENDED AND THE EXTRACORPOREAL (EC) BLOOD WAS NOT RETURNED TO THE PATIENT BOTH TIMES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15121426 ↗
• InjuryMay 20, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY ON A PRISMAX MACHINE, THE OPERATOR ERRONEOUSLY PROGRAMMED THE PATIENT FLUID REMOVAL RATE (PFR) AS THE FLOW RATE PRESCRIBED FOR THE DIALYSATE FLOW RATE (DFR). THE PATIENT FLUID REMOVAL RATE WAS INADVERTENTLY SET TO 1500 ML/HR INSTEAD OF 50 ML/HR. THE ERROR WAS IDENTIFIED AFTER FOUR HOURS INTO TREATMENT AND THE PATIENT BECAME HYPOTENSIVE AND TACHYCARDIC. THE EFFECTIVE ULTRAFILTRATION VOLUME REMOVED FROM THE PATIENT WAS APPROXIMATELY 6L OVER A FOUR HOUR PERIOD (1500 ML/HR X 4). THE ERROR WAS CORRECTED AND THE PATIENT WAS TREATED WITH MULTIPLE VASOACTIVE MEDICATIONS, SODIUM AND CALCIUM (INTRAVENOUSLY), SALINE (1000 ML), LACTATED RINGER (250 ML) AND ALBUMIN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 14461351 ↗
• MalfunctionApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PASSED AWAY WHILE PERFORMING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A PRISMAX CONTROL UNIT. THE CAUSE OF DEATH WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14014199 ↗
• MalfunctionFeb 4, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING THERAPY WITH A PRISMAX DEVICE, AIR WAS OBSERVED IN THE DEAERATION CHAMBER WAS AND THE FILTER WAS OBSERVED TO BE CLOTTED. THE EVENT RESULTED IN THE FILTER BEING CHANGED FOUR TIMES IN ONE SHIFT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13457427 ↗
• MalfunctionDec 30, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A PRISMAX MACHINE V.2, THE PRESET FLUID LOSS/GAIN LIMIT OF 150 CHANGED BY ITSELF TO 400G/3H. NO EXCESSIVE FLUID REMOVAL WAS REPORTED AS IT WAS ONLY THE SET ALARM LIMIT THAT HAD CHANGED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13121572 ↗
• InjurySep 14, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING TREATMENT WITH A PRISMAX CONTROL UNIT, THE PATIENT CODED AND WHILE ATTEMPTING TO PERFORM BLOOD RESTITUTION, THE SCREEN OF THE MACHINE BECAME FROZEN/UNRESPONSIVE. THE AMOUNT OF BLOOD LOSS WAS NOT REPORTED. THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cardiac Arrest

  MAUDE report 12468425 ↗
• MalfunctionAug 3, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT TWO EXTRACORPOREAL CIRCUITS OF BLOOD WERE NOT RETURNED TO THE PATIENT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING PRISMAX MACHINES. THE FIRST TREATMENT WITH THE FIRST MACHINE WAS INTERRUPTED WITHOUT THE EXTRACORPOREAL (EC) BLOOD BEING RETURNED TO THE PATIENT DUE TO CLOT FORMATION IN THE CATHETER. THE CATHETER WAS REPLACED WITH A NEW 15 CM LONG NON-BAXTER CATHETER LOCATED IN THE RIGHT FEMORAL VEIN. THE SECOND TREATMENT WITH THE SECOND MACHINE WAS RUNNING FOR FIFTEEN MINUTES BEFORE A ¿RETURN PRESSURE NEGATIVE¿ ALARM WAS GENERATED. TROUBLESHOOTING WAS UNSUCCESSFUL AND AN ALARM WAS GENERATED INFORMING THE OPERATOR THAT THE BLOOD PUMP HAD BEEN STOPPED FOR TOO LONG. THE ¿BLOOD RETURN¿ FUNCTION WAS ALLEGEDLY GREYED OUT AND TREATMENT WAS ONCE AGAIN TERMINATED WITHOUT BLOOD RETURN. NO PATIENT SYMPTOM OR MEDICAL INTERVENTION WAS REPORTED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12270566 ↗