ICU Medical 42584-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840619027414), received between Jun 26, 2024 and Aug 13, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Imprecision; Imprecision

  AN EVENT INVOLVING A TRANSDUCER, 60 INCH (152 CM), 3 ML/HR, MICRODRIP EXPERIENCED INACCURATE READINGS. THE FOLLOWING ISSUE WAS REPORTED BY THE CUSTOMER: ¿ AN ARTERIAL CATHETER WAS PLACED USING THE KIT FOR MEASURING THE PRESSURE. IT WAS OBSERVED THAT IT INDICATED 45 SYSTOLE ( WHICH DOES NOT MATCH THE PATIENT'S CLINICAL CONDITION ). IT WAS AFTERWARDS OBSERVED THAT IT COULD NOT BE POSSIBLE TO ZERO THE CALIBRATION. THE CATHETER WORKED NORMALLY DURING SAMPLING. ACTIONS TAKEN: A BLOOD PRESSURE MEASUREMENT WITH CUFF SHOWED A DIFFERENCE OF 4 POINTS IN THE PRESSURE. THE TEAM PERFORMED A MODULE AND CABLE CHANGE, WHICH WAS INEFFECTIVE. FINALLY, THE TEAM CHANGED COMPLETELY THE MEASUREMENT KIT, AFTER THE CHANGE THE KIT WAS FUNCTIONAL. THERE WERE NO SERIOUS CONSEQUENCES FOR THE PATIENT, HOWEVER, THE PATIENT APPEARED HYPOTENSIVE WHEN SHE WAS ACTUALLY NORMOTENSIVE, RESULTING IN A LOSS OF TIME. ".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977735 ↗
• MalfunctionJul 3, 2024Break; Failure to Disconnect; Break; Failure to Disconnect

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A TRANSPAC® IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH DEVICE, MACRODRIP WHERE THE CUSTOMER REPORTED THAT THE CURRENT ARTERIAL LINE IS DEFECTIVE. IT IS DIFFICULT TO DISCONNECT AT PATIENT'S SIDE AND FLUSHING DEVICE BREAKS EASILY. THERE WAS PATIENT INVOLVEMENT AND DELAY IN CRITICAL THERAPY. THE CAREGIVER CHANGED TO ANOTHER ARTERIAL LINE TUBING TO ADDRESS THE ISSUE. THERE WAS NO SERIOUS DETERIORATION IN THE STATE OF HEALTH OF A PATIENT, USER, OR OTHER PERSON. THERE WAS NO DEATH OF A PATIENT, USER, OR OTHER PERSON. THERE WAS NO POTENTIAL FOR DEATH OR SERIOUS DETERIORATION IN HEALTH OF A PATIENT, USER, OR OTHER PERSON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19672170 ↗
• MalfunctionJun 26, 2024Crack; Crack

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC® IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH DEVICE, MACRODRIP. THE CUSTOMER STATED THAT THE CURRENT ARTERIAL LINE IS DEFECTIVE. THE FLUSHING DEVICE BREAKS EASILY. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620069 ↗