PRISMAFLEX SET M150Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 07332414090005), received between May 7, 2018 and Aug 18, 2026 — classified as 1 death, 6 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (34 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K080519); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 6, 2026Open, Classified

   There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

   Z-1228-2026 · Root cause: Component design/selection · FDA record ↗

2. Sep 14, 2022Open, Classified

   Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.

   Z-0082-2023 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50303544 ↗
• MalfunctionAug 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237731 ↗
• MalfunctionMay 8, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A PRISMAFLEX M100 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125119 ↗
• MalfunctionApr 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE DRAIN BAG OF A PRISMAFLEX M150 SET AFTER APPROXIMATELY 60 HOURS OF USE FOR CONTINUOUS RENAL REPLACEMENT THERAPY. 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 24971880 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM THE DEAERATION CHAMBER OF A PRISMAFLEX M150 SET AFTER ONE HOUR OF CONTINUOUS RENAL REPLACEMENT THERAPY. THE VOLUME OF BLOOD LOSS WAS NOT KNOWN. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728555 ↗
• MalfunctionJan 8, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE FILTER PRESSURE POD OF A PRISMAFLEX M150 SET WAS OBSERVED TO LEAK DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24010782 ↗
• MalfunctionJun 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER SIX HOURS OF CONTINUOUS RENAL REPLACEMENT THERAPY USING A PRISMAFLEX M SET, A SLIGHT LEAK WAS OBSERVED FROM THE WASTE BAG. IT WAS FURTHER REPORTED THE NURSE TRIED TO SEAL THE LEAK WITHOUT SUCCESS. 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 22141839 ↗
• MalfunctionMay 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRIMING WITH A PRISMAFLEX SETS (M), LEAKING AT THE CONNECTION SITE FROM BOTTOM OF FILTER AT CONNECTION OF EFFLUENT LINE WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096946 ↗
• MalfunctionApr 3, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT A PRISMAFLEX M150 SET WAS OBSERVED TO HAVE A DAMAGED "CABLE" AND LEAKED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767442 ↗
• MalfunctionNov 26, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED CONNECTOR OF A PRISMAFLEX M150 SET WAS BROKEN AND LEAKED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789598 ↗
• InjuryNov 22, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A PRISMAFLEX SET AND A PRISMAX MACHINE, A PATIENT EXPERIENCED A "GAS EMBOLISM". AFTER STOPPING TREATMENT, THE PATIENT WAS DISCONNECTED AND ONE HOUR LATER, THE AIR EMBOLISM WAS CONFIRMED BY A SCANNER. IT WAS REPORTED THE PATIENT HAD SYMPTOMS OF DESATURATION AND NEUROLOGICAL SYMPTOMS. THE PATIENT RECEIVED UNSPECIFIED MEDICAL TREATMENT AND HYPERBARIC CHAMBER SESSIONS. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Air Embolism

  MAUDE report 20762319 ↗
• InjuryJul 15, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A PRISMAFLEX M150 SET, THE NURSE NOTICED A DISCONNECTION "NEAR THE AIR SEPARATION CHAMBER" AND "THE PLASTIC PUMP CAME LOOSE IN FRONT OF THE ROTARY CONNECTION OF THE BLUE" RETURN LINE. IT WAS REPORTED THAT THE "TREATMENTS WERE STOPPED." IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED "SIGNIFICANT BLOOD LOSS" AND REQUIRED A BLOOD TRANSFUSION OF 2 UNITS OF BLOOD. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19745070 ↗
• MalfunctionApr 5, 2024

  PATIENT WAS RECEIVING CONTINUOUS VENOVENOUS HEMODIAFILTRATION (CVVHDF) AND THE CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH THE PRISMA FLEX MACHINE SHUT DOWN WITH SCREEN MESSAGE SAYING CALL SERVICE, SYSTEM FAILURE AND DISCONTINUE TREATMENT. IMMEDIATELY, THE REGISTERED NURSE (RN) FOLLOWED THE INSTRUCTIONS ON THE SCREEN AND RETURNED PATIENT'S BLOOD AND DISCONNECTED THE PATIENT FROM THE MACHINE. A PICTURE OF THE SCREEN MESSAGE WAS TAKEN AND BIOMED CALLED AND SHOWN THE MESSAGE. BIOMED CHECKED THE CRRT MACHINE AND IT WAS OPERATING PROPERLY AND BIOMED CALLED BAXTER TO DISCUSS THE MESSAGE. BAXTER INFORMED BIOMED THE ISSUE COULD BE A PRESSURE POD OR THE CRRT CASSETTE. THE PRESSURE PODS WERE CHECKED AND OPERATING PROPERLY SO THE CRRT CASSETTE WITH M-150 ASSUMED TO BE THE ISSUE. THE RN CHANGED THE PRISMA FLEX MACHINE AND LOADED A NEW CASSETTE WHICH TAKES AT LEAST 20 MINUTES TO PRIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049745 ↗
• MalfunctionFeb 21, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE ACCESS LINE OF A PRISMAFLEX M150 SET DURING PRIMING. A "HOLE" WAS NOTED IN THE TUBING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748131 ↗
• MalfunctionJan 24, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A HAIRLINE CRACK IN THE AIR SEPARATION CHAMBER OF A PRISMAFLEX M150 SET WHICH RESULTED IN A LEAK. THIS ISSUE WAS DISCOVERED DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18571868 ↗
• MalfunctionJan 9, 2024

  PATIENT WAS ON A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) FOR ACUTE KIDNEY INJURY AFTER CARDIAC ARREST. REGISTERED NURSE (RN) NOTED LEAKING OF FLUID FROM SYSTEM. THIS TUBING WAS NOT SAVED BUT STOCK OF SAME LOT # WAS REMOVED FROM SUPPLY. LOT # 23A0094CA. CRRT TUBING ROUTED THROUGH EFFLUENT PUMP CAME DISCONNECTED FROM THE LINE ROUTING THROUGH THE AUTO-EFFLUENT PUMP. THE DRIP CHAMBER WET ALARM WAS SOUNDING. TUBING INSPECTION POST REMOVAL FROM THE CRRT PUMP WAS FOUND COMPLETELY LOOSE. LOT# 23A0056CD. NO HARM TO PATIENT AT EITHER TIME. BACK STOCK OF THIS LOT NUMBER ALSO PULLED FROM SUPPLY. MANUFACTURER RESPONSE FOR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM, PRISMAFLEX SET (PER SITE REPORTER). MANUFACTURER WOULD LIKE IT RETURNED TO THEM FOR EXAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475760 ↗
• MalfunctionJan 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED ORIGINATING FROM THE DIALYSATE PORT OF A PRISMAFLEX M150 SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE NURSE VERIFIED ¿THE CONNECTION WAS TIGHT AND SECURE¿. TREATMENT WAS DISCONTINUED AND THE FILTER WAS REPLACED. THE VOLUME OF BLOOD LOSS WAS NOT REPORTED. 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 18439747 ↗
• MalfunctionDec 29, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE ACCESS (RED STRIPPED) LINE OF FIVE (5) PRISMAFLEX M150 SETS DISCONNECTED FROM BELOW THE RED COUPLING WHICH RESULTED IN AN EXTERNAL BLOOD LEAK. THESE CONNECTION ISSUES OCCURRED DURING TREATMENT WITH CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). 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 18421917 ↗
• MalfunctionDec 27, 2023Crack; Crack

  IT WAS REPORTED THAT THE SMALL GREEN CONNECTOR FOR AN ANTICOAGULANT SYRINGE OF A PRISMAFLEX M150 SET WAS CRACKED. THE CRACKED SET WAS DISCOVERED DURING PRIMING. 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 18404893 ↗
• MalfunctionDec 27, 2023Crack; Crack

  IT WAS REPORTED THAT THE SMALL GREEN CONNECTOR FOR AN ANTICOAGULANT SYRINGE OF A PRISMAFLEX M150 SET WAS CRACKED. THE CRACKED SET WAS DISCOVERED DURING PRIMING. 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 18404789 ↗
• MalfunctionSep 5, 2023Break; Fluid/Blood Leak; Detachment of Device or Device Component; Break; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THE DEAERATION CHAMBER WAS OBSERVED BROKEN WITH A COMPLETELY DETACHED RETURN LINE AND IT IS ASSUMED THAT EXTERNAL BLOOD LEAKAGE OCCURRED FROM A PRISMAFLEX M150 SET. THIS EVENT WAS OBSERVED DURING TREATMENT FOR CONTINUOUS RENAL REPLACEMENT THERAPY. TREATMENT WAS TERMINATED WITHOUT RETURNING THE EXTRACORPOREAL (EC) BLOOD TO THE PATIENT. 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 17683352 ↗
• MalfunctionAug 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED ORIGINATING ¿AT THE TRANSITION BETWEEN THE THICK AND THE THIN HOSE SEGMENT¿ OF A PRISMAFLEX M150 SET DURING PRIME. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17591993 ↗
• MalfunctionJul 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL BLOOD LEAK WAS OBSERVED ORIGINATING FROM THE CONNECTION BETWEEN THE SYRINGE AND SYRINGE LINE OF A PRISMAFLEX M150 DURING CONTINUOUS VENO-VENOUS HEMODIAFILTRATION. APPROXIMATELY ONE HOUR INTO THERAPY; SHORTLY AFTER STARTING THE HEPARIN, THE BLOOD ¿BACKED UP INTO THE SYRINGE LINE AND STARTED LEAKING FROM THE CONNECTION BETWEEN THE SYRINGE LINE AND SYRINGE¿. THE BLOOD LOSS WAS APPROXIMATELY 100-200ML. 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 17352200 ↗
• MalfunctionMay 30, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING TREATMENT WITH CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A PRISMAFLEX CONTROL UNIT, A PRISMAFLEX M150 SET, AN ALARM CONDITION RELATED TO 'AIR IN BLOOD' WAS GENERATED AND ¿CLOTS THROUGHOUT THE ENTIRE DEAERATION CHAMBER AND CLOTS AT THE BOTTOM¿ THAT WERE PREVENTING THE AIR FROM BEING REMOVED FROM THE RETURN LINE WERE NOTED. 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 17023226 ↗
• MalfunctionMar 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN INTERNAL BLOOD LEAKAGE WAS OBSERVED IN TWO (2) PRISMAFLEX M150 SETS. SHORTLY AFTER STARTING CONTINUOUS RENAL REPLACEMENT THERAPY THE DEAERATION CHAMBER AND CHAMBER LINE (RETURN PRESSURE MONITORING LINE) FILLED WITH BLOOD, AND THE RETURN EXTREMELY NEGATIVE ALARM WAS TRIGGERED. THE HYDROPHOBIC MEMBRANE AT THE END OF RETURN PRESSURE MONITORING LINE WAS OBSERVED TO HAVE BECOME WET, AND THE TREATMENT WAS ENDED WITHOUT THE EXTRACORPOREAL (EC) BLOOD BEING RETURNED TO THE PATIENT. SHORTLY AFTER RESTARTING THERAPY ON ANOTHER SET, THE SAME ISSUE REOCCURRED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16648999 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080519. One submission often covers many models, so check the product and lot details in each record.

• Z-2203-2014 · Jul 18, 2014 · Terminated
  Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box