Solex 7 CO Kit, Applause Custom Luer SL-2593CORecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849111075541), received between Dec 1, 2017 and Dec 1, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2017Leak/Splash; Leak/Splash

  AS REPORTED, THE SOLEX CATHETER WAS OBSERVED TO HAVE A LEAK. ACCORDING TO THE REPORTER, THERE WAS NO ALARMS NOTED FROM THE THERMOGARD XP IVTM CONSOLE. APPROXIMATELY 6 HOURS INTO THE PATIENT THERAPY, THE ATTENDING NURSE NOTED THAT THE 500 CC BAG OF SALINE WAS EMPTY. THE BAG WAS REPLACED WITH A 1000 CC BAG AND ABOUT 4 HOURS LATER, THE NURSE NOTED THE BAG HAD LOST 500 CC OF SALINE. THE HEALTH CARE TEAM ULTIMATELY DECIDED TO DISCONTINUE THE SOLEX AND PLACE A FEMORAL LINE USING THE QUATTRO CATHETER. NO FURTHER ISSUES WERE NOTED. THERE WERE NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7077610 ↗