ICU Medical CH3187Recalls & reported problems
Icu Medical, Inc. · 15" (38 cm) Appx 5.2 ml, Bifuse Add-On Set w/Bag Spike, Spiros™, 3 Clamps (Blue, Red, White), Dry Spike Adapter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840619025335), received between May 19, 2024 and Oct 22, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE FOLLOWING DEVICE: 15" (38 CM) APPX 5.2 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS¿, 3 CLAMPS (BLUE, RED, WHITE), DRY SPIKE ADAPTER REPORTEDLY LEAKED AT THE SPIRO DURING A PATIENT'S (SECOND) CISPLATIN INFUSION. IT WAS STATED IN THE REPORT THAT PACLITAXEL INFUSION WAS OK INITIALLY BEFORE THE LEAK DURING THE SECOND INFUSION. THERE WAS NO BLEED BACK REPORTED. THERE WAS NO PATIENT HARM NOR ANY DELAY IN CRITICAL THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23363302 ↗MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT INVOLVED 15" (38 CM) APPX 5.2 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS¿, 3 CLAMPS (BLUE, RED, WHITE), DRY SPIKE ADAPTER WHERE IT WAS REPORTED THAT A CHEMOTHERAPY DRUG LEAKED AT THE CONNECTION SITE DURING INFUSION. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THERE WAS NO DELAY IN CRITICAL THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23294164 ↗MalfunctionAug 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
AN EVENT OCCURRED INVOLVING A 15" (38 CM) APPX 5.2 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS¿, 3 CLAMPS (BLUE, RED, WHITE), DRY SPIKE ADAPTER THAT REPORTEDLY LEAKED CISPLATIN DURING INFUSION. THERE WAS NO BLEED BACK REPORTED. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM/ADVERSE EVENT AND NO DELAY IN CRITICAL THERAPY AS A RESULT OF THIS EVENT. ONLY ONE (1) SAMPLE DEVICE WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22709610 ↗MalfunctionJul 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
A 15" (38 CM) APPX 5.2 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS¿, 3 CLAMPS (BLUE, RED, WHITE), DRY SPIKE ADAPTER THAT REPORTEDLY LEAKED 5-FU FROM THE DEVICE AT THE SPIROS CONNECTION DURING A PATIENT INFUSION. THE THE PROBLEM COULDN¿T BE SOLVED WHEN THEY CHANGED THE CH3187. A CONCOMITANT DEVICE WAS NOT USED. THERE WAS NO BLEED BACK, NO PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22538195 ↗MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT INVOLVED A 15" (38 CM) APPX 5.2 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS¿, 3 CLAMPS (BLUE, RED, WHITE), DRY SPIKE ADAPTER WHERE A CHEMO LEAKAGE FROM SPIROS DURING INFUSION WAS REPORTED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED. THERE WAS NO DELAY IN CRITICAL THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22322883 ↗MalfunctionMay 19, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE COMPLAINT/EVENT INVOLVED A 15" (38 CM) APPX 5.2 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS¿, 3 CLAMPS (BLUE, RED, WHITE), DRY SPIKE ADAPTER THAT REPORTEDLY LEAKED AN UNSPECIFIED CHEMOTHERAPY DRUG DURING AN INFUSION. NO CONCOMITANT DEVICE, NO BLEED BACK, NO DELAY IN CRITICAL THERAPY AND NO PATIENT HARM WAS ASSOCIATED WITH THE COMPLAINT/EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19348458 ↗
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
Other Set, administration, intravascular devices
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- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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