ICU Medical 42645-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619064464), received between Apr 19, 2022 and Apr 19, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Disconnection” (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.

• MalfunctionApr 19, 2022Disconnection; Disconnection

  THE DEVICE INVOLVED IS A TRANSPAC IV MONITORING KIT. THE CUSTOMER STATED THAT UPON ATTEMPTING TO PULL BLOOD BACK IN THE SAFE SET ARTERIAL LINE TUBING FROM THE ARTERIAL LINE PLACED IN THE RIGHT RADIAL ARTERY, THE TUBING BECAME DISCONNECTED FROM THE STOP COCK RESULTING IN A SMALL AMOUNT OF BLEEDING BACK FROM THE PATIENT DUE TO THE OPEN ENDED ARTERIAL LINE. UPON ATTEMPTING TO RECONNECT THE TUBING AND RETURN THE WASTE BLOOD FROM THE SAFE SET TO THE PATIENT; THE LINE AGAIN BECAME DISCONNECTED AT THE SAME POINT AND AGAIN BLOOD SPRAYED FROM THE LINE. THE LINE WAS IMMEDIATELY CLAMPED OFF AND THE ACTUAL BLOOD LOSS WAS MINIMAL (APPROXIMATELY 3 ML AT MOST). THE ENTIRE SET WAS THEN CHANGED OUT. THE LINE WAS EASILY FLUSHED AND HAD IMMEDIATE BRISK BLOOD RETURN. THERE WAS NO CHANGE IN CIRCULATION DISTALLY TO THE LINE AND TRANSDUCING CONTINUED WITHOUT INCIDENT. THE PATIENT DID NOT EXPERIENCE PAIN OR DISCOMFORT. THIS WAS A NEW SET UP THAT HAD BEEN HOOKED UP TO THE PATIENT AT 2200. NO LEAKS OR DEFECTS WERE OBSERVED WHEN PRIMING THE LINE. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14142530 ↗