ICU Medical CH2000-PCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840619023812), received between Oct 29, 2021 and Sep 11, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K070532); they may or may not involve this specific model.

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.

• MalfunctionSep 11, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735855 ↗
• MalfunctionJul 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A SPIROS CLOSED MALE LUER, PURPLE CAP. THE COMPLAINANT REPORTED THAT THERE WAS A LEAKING ISSUE ON THIS CLOSED SYSTEM DRUG-TRANSFER DEVICE (CTSD) AND LAB TESTING WAS REQUESTED. THERE WAS NO REPORT OF HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305054 ↗
• MalfunctionOct 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SPIROS CLOSED MALE LUER WITH PURPLE CAP. IT WAS REPORTED THAT MICROBORE TUBING WITH SPIROS CAPS APPLIED TO ALL CONNECTION SITES WAS USED TO INFUSE CHEMOTHERAPY (CYCLOPHOSPHAMIDE) ON A SYRINGE PUMP AND PROGRAMMED TO INFUSE OVER AN HOUR. AFTER INFUSION AND FLUSH WAS COMPLETED BY THE NURSE IT WAS REPORTED THAT SHE NOTICED A WET SPOT ON THE CHUX PAD UNDER THE PATIENT. THE NURSE NOTICED DRIPPING FROM THE CONNECTION SITE WHERE THE CHEMO HAD BEEN INFUSING. SHE REPORTED IT WAS COMING FROM WHERE THE SPIROS CONNECTS TO THE CLAVE OF THE BIFUSE WHICH ATTACHES TO THE PATIENT¿S CENTRAL LINE. IT WAS REPORTED THAT MOST, IF NOT ALL THE CHEMO LEAKED INTO THE PATIENT¿S BED. THE BONE MARROW TEAM AND PHARMACIST WERE NOTIFIED, AND IT WAS DECIDED TO ADMINISTER HALF OF THE ORIGINAL DOSE TO THE PATIENT. THEREFORE, THE SET UP WAS CHANGED OUT AND THE PATIENT WAS RE-DOSED WITHOUT ANY FURTHER ISSUES. THERE WAS PATIENT INVOLVEMENT HOWEVER NO REPORT OF HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12720682 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070532. One submission often covers many models, so check the product and lot details in each record.

• Z-0699-2021 · Aug 31, 2020 · Open, Classified
  42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, RE