ICU Medical CH3381Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840619066284), received between Feb 3, 2020 and Feb 3, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 16" (41 CM) APPX 4.4 ML, EXT SET W/MICROCLAVE®, 0.2 MICRON FILTER, CLAVE®, SPIROS®, CLAMP THAT THE CUSTOMER REPORTED A LEAK OF ETOPOSIDE FROM THE AIR VENTS OF THE 0.2 MICRON FILTER. THE 24 HOUR ETOPOSIDE INFUSION WAS ADMINISTERING VIA A SECONDARY ADMINISTRATION SET THAT WAS LUER LOCKED INTO THE BD PRIMARY LINE AT THE UPPER Y-SITE. THE CUSTOMER REPORTED THE 16" (41 CM) APPX 4.4 ML, EXT SET W/MICROCLAVE®, 0.2 MICRON FILTER, CLAVE®, SPIROS®, CLAMP WAS ATTACHED TO THE DISTAL END OF THE BD PRIMARY LINE AND WAS LUER LOCKED INTO THE PATIENT¿S PORT. DURING THE 13TH HOUR OF THE INFUSION THE NURSE IDENTIFIED THE LEAK DURING HER HOURLY LINE CHECK. IT WAS IDENTIFIED THAT THE FILTER WAS IN THE UPRIGHT POSITION HANGING FROM THE PATIENT¿S PORT (INLET OVER OUTLET). IT WAS MENTIONED THE SAFETY PIN WAS USED TO SECURE THE SET TO THE PATIENT CLOTHING DURING ADMINISTRATION IN ORDER TO KEEP THE FILTER IN THE RIGHT ORIENTATION. NEITHER THE NURSE NOR THE PATIENT EXPERIENCED ADVERSE EVENTS, HOWEVER BOTH EXPERIENCED ENVIRONMENTAL EXPOSURE. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO REPORT OF ADVERSE EVENT.

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

  MAUDE report 9662228 ↗
• MalfunctionFeb 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 16" (41 CM) APPX 4.4 ML, EXT SET W/MICROCLAVE®, 0.2 MICRON FILTER, CLAVE®, SPIROS®, CLAMP THAT THE CUSTOMER REPORTED A LEAK OF ETOPOSIDE FROM THE AIR VENTS OF THE 0.2 MICRON FILTER. THE 24 HOUR ETOPOSIDE INFUSION WAS ADMINISTERING VIA A SECONDARY ADMINISTRATION SET THAT WAS LUER LOCKED INTO THE BD PRIMARY LINE AT THE UPPER Y-SITE. THE CUSTOMER REPORTED THE 16" (41 CM) APPX 4.4 ML, EXT SET W/MICROCLAVE®, 0.2 MICRON FILTER, CLAVE®, SPIROS®, CLAMP WAS ATTACHED TO THE DISTAL END OF THE BD PRIMARY LINE AND WAS LUER LOCKED INTO THE PATIENT¿S PORT. DURING THE 13TH HOUR OF THE INFUSION THE NURSE IDENTIFIED THE LEAK DURING HER HOURLY LINE CHECK. IT WAS IDENTIFIED THAT THE FILTER WAS IN THE INVERTED POSITION HANGING FROM THE PATIENT¿S PORT (OUTLET OVER INLET). NEITHER THE NURSE NOR THE PATIENT EXPERIENCED ADVERSE EVENTS, HOWEVER BOTH EXPERIENCED ENVIRONMENTAL EXPOSURE. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO REPORT OF ADVERSE EVENT.

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

  MAUDE report 9662150 ↗

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