ICU Medical CH3379Recalls & reported problems
Icu Medical, Inc. · 7" (18 cm) Appx 0.40 ml, Smallbore Bifuse Ext Set w/2 MicroClave™ Clear, Spiros™, 2 Clamps · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619066543), received between Aug 2, 2017 and Aug 2, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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
Device problems
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 2, 2017Leak/Splash; Leak/Splash
COMPLAINT RECEIVED REGARDING ONE CH3379. REPORT STATES: WHILE ADMINISTERING VISCRISTINE WITH THE BIFUSE TUBING THE MEDICATION BEGAN LEAKING OUT OF THE CONNECTION FROM THE TUBING TO THE PATIENT'S MEDIPORT. IT DID NOT GET ON THE PATIENT BUT A DROP OR TWO FELL ON HER MOM'S HAND. SHE IMMEDIATELY AND THOROUGHLY WASHED HER HANDS AND NO IRRITATION WAS NOTED. NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6759694 ↗
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, Classified42 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
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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