PRISMAFLEX TPE 2000 SET 114093Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07332414111038), received between Dec 20, 2019 and Dec 28, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 FDA recall record name this device's identifier, 1 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. Jan 6, 2026Class IIOpen, Classified

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

   Z-1231-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PRIMING OF A PRISMAFLEX TPE2000 SET, AN EXTERNAL FLUID LEAK WAS NOTED AT THE TOP OF THE FILTER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16062114 ↗
• MalfunctionOct 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING SET UP WITH A PRISMAFLEX TPE2000 SET, AN EXTERNAL FLUID LEAK AT THE FILTER PRESSURE POD WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580912 ↗
• MalfunctionMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WITHIN THE FIRST FEW MINUTES OF THERAPEUTIC PLASMA EXCHANGE WITH A PRISMAFLEX TPE2000, A BLOOD LEAK DETECTOR ALARM WAS TRIGGERED AND AN INTERNAL BLOOD LEAK WAS IDENTIFIED. VISIBLE BLOOD TINGED EFFLUENT WAS OBSERVED IN THE EFFLUENT LINE AND THE DRAIN BAG. VISIBLE BLOOD WAS ALSO OBSERVED ON THE OUTSIDE OF THE FILTER SEMI-PERMEABLE MEMBRANE FIBERS. TREATMENT WAS STOPPED WITHOUT BLOOD RETURN. A TOTAL OF 125ML OF BLOOD WAS LOST. THE PATIENT WAS STABLE AND THE VITAL SIGNS WERE NORMAL. WITHIN TWENTY (20) MINUTES OF STARTING A NEW TPE TREATMENT THE PATIENT BECAME PALE AND PRESENTED WITH WEAKNESS, NAUSEA AND VOMITING. THE BLOOD PRESSURE READING WAS 84/43 MMHG. THE PATIENT WAS TREATED WITH AN UNSPECIFIED AMOUNT OF SALINE. THE PATIENT REPORTED THEY WERE NOT FEELING WELL AND TREATMENT WAS INTERRUPTED WITH BLOOD RETURN AND ANOTHER 30 ML SALINE WAS PROVIDED. THE PATIENT 'S CONDITION SUBSEQUENTLY IMPROVED, AND THE BLOOD PRESSURE INCREASED TO 110/60 MMHG. TPE TREATMENT WAS SUSPENDED FOR THE DAY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Low Blood Pressure/ Hypotension; Muscle Weakness/Atrophy; Nausea; Vomiting

  MAUDE report 13970927 ↗
• MalfunctionNov 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING A PRISMAFLEX TPE2000 SET, BLOOD WAS OBSERVED BACKING TOWARDS THE HEPARIN SYRINGE AND EXTERNAL FLUID LEAKAGE WAS OBSERVED AT THE NON-RETURN VALVE LOCATED IN THE HEPARIN LINE. THE PATIENT WAS CONNECTED FOR THERAPY AT THE TIME OF THIS EVENT. TO RESOLVE THIS ISSUE, THE CUSTOMER CHANGED THE SET. 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 12844565 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A PATIENT COMPLETED THERAPEUTIC PLASMA EXCHANGE TREATMENT #4, USING A PRISMAFLEX TPE2000 SET, THE PATIENT COMPLAINED OF ITCHING AND BODY RASH. ALBUMIN SOLUTION (2 LITER) WAS USED AS EXCHANGE. THE PATIENT WAS TREATED FOR THE EVENT WITH MAGNESIUM INTRAVENOUSLY (DOSE NOT REPORTED) AND BENADRYL INTRAVENOUSLY ( DOSE NOT REPORTED). THE PATIENT LATER EXPERIENCED A DROP IN BLOOD PRESSURE (66/49 MMHG), DROP IN OXYGEN SATURATION (REPORTED AS A DROP INTO THE 80S) AND THE PATIENT BECAME UNRESPONSIVE. LEVOPHED AND DOPAMINE ( DOSE AND ROUTE OF ADMINISTRATION WAS NOT REPORTED) WAS ADMINISTERED AS TREATMENT. AT THE TIME OF THIS REPORT, THE PATIENT WAS REPORTED TO BE DOING WELL AND WAS ON OXYGEN (PER NASAL CANNULA) AND TREATMENT WITH LEVOPHED WAS ONGOING (LOW DOSE). THE PATIENT'S RASH WAS REPORTED TO BE "ALMOST COMPLETELY RESOLVED". IT WAS ALSO REPORTED THE PATIENT ALSO COMPLAINED OF ITCHING ONE DAY PRIOR TO THIS EVENT AND WAS TREATED WITH BENADRYL ORALLY (DOSE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 10416296 ↗
• MalfunctionDec 20, 2019Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT AFTER STARTING THERAPEUTIC PLASMA EXCHANGE (TPE) TREATMENT USING FOUR PRISMAFLEX TPE SETS, CLOTTING SITING ¿ACCESS ISSUES¿ WAS OBSERVED. IT WAS REPORTED THAT ACCESS WAS INTACT AND PATENT. IT WAS REPORTED TREATMENT WAS STARTED WITH -50 TO -80 AND AFTER FIVE TO TEN MINUTES, THE ACCESS WOULD JUMP TO OVER -250. TREATMENT WAS DISCONTINUED, AND THE EXTRACORPOREAL (EC) BLOOD WAS RETURNED TO THE PATIENT AFTER THE FIRST EVENT; HOWEVER, IT WAS UNKNOWN IF THE EC BLOOD WAS RETURNED FOR THE SUBSEQUENT EVENTS. IT WAS REPORTED A NEW TPE2000 WAS PREPARED; HOWEVER, THE EVENT OCCURRED AGAIN WITH "ONE TO TWO FILTER SETS". A TPE2000 SET WITH A DIFFERENT LOT NUMBER WAS THEN PREPARED AND TREATMENT WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9507114 ↗