CO-SET+ 93505Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07460691949973), received between Apr 30, 2024 and Dec 5, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHEN MONITORING THE PATIENT AS PART OF POSTOPERATIVE CARE, THIS CO-SET WAS CRACKED CAUSING BLOOD LEAKAGE SPILLED ON TO THE BED. THERE IS NO FURTHER INFORMATION AVAILABLE. AS PER PRODUCT EVALUATION FINDINGS, THE MANIFOLD OF THIS CO-SET WAS COMPLETELY BROKEN. PATIENT DEMOGRAPHICS WERE NOT AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20853239 ↗
• MalfunctionSep 27, 2024Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  AS REPORTED, DURING USE IN PATIENT WITH THIS MANIFOLD, IT BROKE DURING THE MOBILIZATION PROCEDURE AND A BLOOD LEAKAGE WAS PRODUCED. TO SOLVE THE ISSUE THE DEVICE WAS REPLACED. AS PER THE HOSPITAL INFORMATION THE PHARMACEUTICAL SERVICE, CONFIRMED THAT THERE WAS AN EVIDENT LEAK THROUGH THE THERMISTOR CABLE WAS CONNECTED. THE AMOUNT OF BLOOD LOST BY THE PATIENT WAS NOT MEASURED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. IT WAS DISCARDED AS THE DEVICE WAS HEAVILY IMPREGNATED WITH THE PATIENT'S BLOOD.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20320087 ↗
• MalfunctionMay 22, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, WHEN INJECTING THE BOLUS TO MEASURE CARDIAC OUTPUT, THE CO-SET MANIFOLD WAS FOUND TO HAVE A CRACK AT THE FEMALE LUER AND SALINE LEAKED. THEREFORE, CARDIAC OUTPUT VALUES WERE 8.5L/MIN, WHILE AS PER PATIENT'S CONDITION IT SHOULD BE 6L/MIN. REPLACING THE CO-SET MANIFOLD THE ISSUE WAS SOLVED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19368605 ↗
• MalfunctionMay 21, 2024Fluid/Blood Leak; Incorrect Measurement; Fluid/Blood Leak; Incorrect Measurement

  AS REPORTED, WHEN INJECTING THE BOLUS TO MEASURE CARDIAC OUTPUT, THE CO-SET MANIFOLD WAS FOUND TO HAVE A CRACK AT THE FEMALE LUER AND SALINE LEAKED. THEREFORE, CARDIAC OUTPUT VALUES WERE 8.5L/MIN, WHILE AS PER PATIENT'S CONDITION IT SHOULD BE 6L/MIN. REPLACING THE CO-SET MANIFOLD THE ISSUE WAS SOLVED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19357254 ↗
• MalfunctionMay 21, 2024Fluid/Blood Leak; Incorrect Measurement; Fluid/Blood Leak; Incorrect Measurement

  AS REPORTED, WHEN INJECTING THE BOLUS TO MEASURE CARDIAC OUTPUT, THE CO-SET MANIFOLD WAS FOUND TO HAVE A CRACK AT THE FEMALE LUER AND SALINE LEAKED. THEREFORE, CARDIAC OUTPUT VALUES WERE 8.5L/MIN, WHILE AS PER PATIENT'S CONDITION IT SHOULD BE 6L/MIN. REPLACING THE CO-SET MANIFOLD THE ISSUE WAS SOLVED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19357235 ↗
• MalfunctionMay 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED, WHEN INJECTING THE BOLUS TO MEASURE CARDIAC OUTPUT, THE CO-SET MANIFOLD WAS FOUND TO HAVE A CRACK AT THE FEMALE LUER AND SALINE LEAKED. THEREFORE, CARDIAC OUTPUT VALUES WERE 8.5L/MIN, WHILE AS PER PATIENT'S CONDITION IT SHOULD BE 6L/MIN. REPLACING THE CO-SET MANIFOLD THE ISSUE WAS SOLVED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19357074 ↗
• MalfunctionApr 30, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT, THE MANIFOLD OF THIS CO-SET BROKE. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213290 ↗
• MalfunctionApr 30, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED, IN SEVERAL OCCASION DURING USE IN PATIENT, THIS MANIFOLD BROKE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213004 ↗
• MalfunctionApr 30, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED, DURING USE, SEVERAL TIMES IN THE PAST, THE MANIFOLD OF THIS CO-SET BROKE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS WERE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212722 ↗