ICU Medical CH-74-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840619065706), received between Sep 14, 2020 and Sep 14, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K080989); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE AND INVOLVED A LOCKING UNIVERSAL VENTED VIAL SPIKE, CLAVE, 10 UNITS THAT LEAKED CHEMOTHERAPY DURING PREPARATION. THE CUSTOMER REPORTED THAT SEVERAL PREPARERS HAD LEAKAGE ISSUES. THEY FOUND THE FILTER ASSOCIATED WITH THE SPIKE WAS NOT WORKING. AS A RESULT, LEAKS WERE OBSERVED AS WELL AS OVERPRESSURE INSIDE THE BOTTLE CAUSING PROJECTION INSIDE THE ENCLOSURE WHEN THE SPIKE IS REMOVED FROM THE BOTTLE. THE DRUGS INVOLVED WERE PACLITAXEL, ETOPOSIDE, AND DOCETAXEL (FAIRLY VISCOUS CHEMOTHERAPY). ADDITIONALLY, THE CUSTOMER STATED THERE WAS AN UNPROTECTED EXPOSURE TO CHEMOTHERAPY CAUSING THE CONTAMINATION OF THE PREPARER (GLOVES, JACKET), THE BOTTLE TO BE DISCARDED EACH TIME (FINANCIAL LOSS), CHANGING OF GLOVES, CHANGING THE STERILE FIELD AND CLEANING THE LAMINAR FLOW CHAMBER. THE SPILL WAS CLEANED PER PROTOCOL. NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED FOUR INCIDENTS. THIS REPORT CAPTURES THE FOURTH OF FOUR INCIDENTS.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 10529001 ↗
• MalfunctionSep 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE AND INVOLVED A LOCKING UNIVERSAL VENTED VIAL SPIKE, CLAVE, 10 UNITS THAT LEAKED CHEMOTHERAPY DURING PREPARATION. THE CUSTOMER REPORTED THAT SEVERAL PREPARERS HAD LEAKAGE ISSUES. THEY FOUND THE FILTER ASSOCIATED WITH THE SPIKE WAS NOT WORKING. AS A RESULT, LEAKS WERE OBSERVED AS WELL AS OVERPRESSURE INSIDE THE BOTTLE CAUSING PROJECTION INSIDE THE ENCLOSURE WHEN THE SPIKE IS REMOVED FROM THE BOTTLE. THE DRUGS INVOLVED WERE PACLITAXEL, ETOPOSIDE, AND DOCETAXEL (FAIRLY VISCOUS CHEMOTHERAPY). ADDITIONALLY, THE CUSTOMER STATED THERE WAS AN UNPROTECTED EXPOSURE TO CHEMOTHERAPY CAUSING THE CONTAMINATION OF THE PREPARER (GLOVES, JACKET), THE BOTTLE TO BE DISCARDED EACH TIME (FINANCIAL LOSS), CHANGING OF GLOVES, CHANGING THE STERILE FIELD AND CLEANING THE LAMINAR FLOW CHAMBER. THE SPILL WAS CLEANED PER PROTOCOL. NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED FOUR INCIDENTS. THIS REPORT CAPTURES THE SECOND OF FOUR INCIDENTS.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 10528998 ↗
• MalfunctionSep 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE AND INVOLVED A LOCKING UNIVERSAL VENTED VIAL SPIKE, CLAVE, 10 UNITS THAT LEAKED CHEMOTHERAPY DURING PREPARATION. THE CUSTOMER REPORTED THAT SEVERAL PREPARERS HAD LEAKAGE ISSUES. THEY FOUND THE FILTER ASSOCIATED WITH THE SPIKE WAS NOT WORKING. AS A RESULT, LEAKS WERE OBSERVED AS WELL AS OVERPRESSURE INSIDE THE BOTTLE CAUSING PROJECTION INSIDE THE ENCLOSURE WHEN THE SPIKE IS REMOVED FROM THE BOTTLE. THE DRUGS INVOLVED WERE PACLITAXEL, ETOPOSIDE, AND DOCETAXEL (FAIRLY VISCOUS CHEMOTHERAPY). ADDITIONALLY, THE CUSTOMER STATED THERE WAS AN UNPROTECTED EXPOSURE TO CHEMOTHERAPY CAUSING THE CONTAMINATION OF THE PREPARER (GLOVES, JACKET), THE BOTTLE TO BE DISCARDED EACH TIME (FINANCIAL LOSS), CHANGING OF GLOVES, CHANGING THE STERILE FIELD AND CLEANING THE LAMINAR FLOW CHAMBER. THE SPILL WAS CLEANED PER PROTOCOL. NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED FOUR INCIDENTS. THIS REPORT CAPTURES THE THIRD OF FOUR INCIDENTS.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 10528997 ↗
• MalfunctionSep 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE AND INVOLVED A LOCKING UNIVERSAL VENTED VIAL SPIKE, CLAVE, 10 UNITS THAT LEAKED CHEMOTHERAPY DURING PREPARATION. THE CUSTOMER REPORTED THAT SEVERAL PREPARERS HAD LEAKAGE ISSUES. THEY FOUND THE FILTER ASSOCIATED WITH THE SPIKE WAS NOT WORKING. AS A RESULT, LEAKS WERE OBSERVED AS WELL AS OVERPRESSURE INSIDE THE BOTTLE CAUSING PROJECTION INSIDE THE ENCLOSURE WHEN THE SPIKE IS REMOVED FROM THE BOTTLE. THE DRUGS INVOLVED WERE PACLITAXEL, ETOPOSIDE, AND DOCETAXEL (FAIRLY VISCOUS CHEMOTHERAPY). ADDITIONALLY, THE CUSTOMER STATED THERE WAS AN UNPROTECTED EXPOSURE TO CHEMOTHERAPY CAUSING THE CONTAMINATION OF THE PREPARER (GLOVES, JACKET), THE BOTTLE TO BE DISCARDED EACH TIME (FINANCIAL LOSS), CHANGING OF GLOVES, CHANGING THE STERILE FIELD AND CLEANING THE LAMINAR FLOW CHAMBER. THE SPILL WAS CLEANED PER PROTOCOL. NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED FOUR INCIDENTS. THIS REPORT CAPTURES THE FIRST OF FOUR INCIDENTS.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 10528992 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080989. One submission often covers many models, so check the product and lot details in each record.

• Z-0710-2021 · Aug 31, 2020 · Open, Classified
  Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260