therMaxTherMax Blood Warmer 955516Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07332414123932), received between Jan 4, 2022 and Mar 2, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 reports).

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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED AT THE CONNECTION OF A PRISMAFLEX ST150 SET AND A THERMAX BLOOD WARMER DISPOSABLE DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE VOLUME OF BLOOD LOSS WAS NOT KNOWN. THE SET WAS REPLACED WITHOUT THE EXTRACORPOREAL BLOOD BEING RETURNED TO THE PATIENT. 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 24489621 ↗
• MalfunctionFeb 23, 2026Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE LUER LOCK CONNECTION BETWEEN A PRISMAFLEX ST150 SET AND A THERMAX BLOOD WARMER DISPOSABLE WAS LOOSE AND ALLOWED BLOOD LEAKAGE DURING CONTINUOUS RENAL REPLACEMENT THERAPY, DESCRIBED AS "BLOOD WAS SPRAYED OVER THREE NURSES". THE VOLUME OF BLOOD LOSS WAS NOT KNOWN. THE EXTRACORPOREAL BLOOD WAS NOT RETURNED TO THE PATIENT. 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 24421541 ↗
• MalfunctionJan 21, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A "CONTAMINATE" WAS OBSERVED IN THE PORT TUBING OF A THERMAX BLOOD WARMER DISPOSABLE, DESCRIBED AS "CLEAR PORT HAS PAPER SHRED INSIDE". THIS WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136367 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CLOTTING WAS OBSERVED IN A THERMAX BLOOD WARMER DISPOSABLE DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAX MACHINE. IT WAS ADDITIONALLY REPORTED THAT THERE WAS A "POSSIBLE BLOOD ADMINISTRATION DUE TO FILTER LOSS". NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 23597761 ↗
• MalfunctionOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PATIENT TREATMENT USING A THERMAX BLOOD WARMER, "THE CONNECTION/SNAP BETWEEN THE THERMAX BLOOD WARMER SET AND THE PRISMAFLEX SET BREAKS AND BLOOD STARTS FLOWING." TREATMENT WAS DISCONTINUED. 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 23383627 ↗
• MalfunctionSep 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A BLOOD LEAK WAS OBSERVED ORIGINATING AT THE CONNECTION BETWEEN THE THERMAX BLOOD WARMER DISPOSABLE AND A PRISMAFLEX ST150 SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE LEAK WAS ¿TOWARDS THE AIR SEPARATION CHAMBER". THE VOLUME OF BLOOD LOSS WAS APPROXIMATELY 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 17817932 ↗
• MalfunctionSep 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM A THERMAX BLOOD WARMER DISPOSABLE. THIRTY MINUTES INTO CONTINUOUS RENAL REPLACEMENT THERAPY THE LEAK WAS OBSERVED FROM THE LUER LOCK CONNECTION BETWEEN THE THERMAX DISPOSABLE AND THE RETURN BLOOD LINE OF THE PRISMAFLEX HP-X SET. TREATMENT WAS DISCONTINUED WITHOUT BLOOD RESTITUTION AND THE ACCUMULATED BLOOD LOSS WAS 192ML. 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 17691138 ↗
• MalfunctionMay 31, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A PRISMAX MACHINE EQUIPPED WITH A THERMAX BLOOD WARMER, A MINOR EXTERNAL BLOOD LEAK WAS OBSERVED FROM THE LUER LOCK CONNECTION BETWEEN THE THERMAX DISPOSABLE AND THE RETURN BLOOD LINE OF THE PRISMAFLEX ST150 SET, RESULTING IN A SMALL BLOOD CLOT. 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 17034099 ↗
• MalfunctionSep 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER TEN HOURS OF CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A PRISMAFLEX ST100 SET AND A PRISMAX MACHINE EQUIPPED WITH A THERMAX BLOOD WARMER, AN EXTERNAL BLOOD LEAK (179ML) WAS OBSERVED BETWEEN THE ST100 SET POSTER FILTER LUER CONNECTION AND THE THERMAX WARMER LUER CONNECTION. 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 15378544 ↗
• MalfunctionMay 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A PRISMAX MACHINE EQUIPPED WITH A THERMAX BLOOD WARMER, A MINOR EXTERNAL BLOOD LEAK WAS OBSERVED FROM THE LUER LOCK CONNECTION BETWEEN THE THERMAX DISPOSABLE AND THE RETURN BLOOD LINE OF THE PRISMAFLEX ST150 SET, RESULTING IN A SMALL BLOOD CLOT. THE TREATMENT WAS ENDED AND THE EXTRACORPOREAL BLOOD WAS RETURNED 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 14522027 ↗
• MalfunctionJan 4, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATE MATTER (PM) WAS OBSERVED IN THE STERILE BAG TUBE OF A THERMAX BLOOD WARMER DISPOSABLE. THE PM WAS FURTHER DESCRIBED AS A ¿HAIR¿ AND WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158171 ↗