Level 1 D-60HLRecalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20695085406003), received between Aug 16, 2021 and May 19, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak4
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A MALFUNCTION/LEAKING SET RECENTLY. THE LEAKING OCCURRED WHERE THE SPIKE MET THE TUBING WHERE YOU SPIKE THE BLOOD PRODUCT. THEY WERE NOT ABLE TO SAVE THE TUBING SINCE IT HAD BLOOD PRODUCT WITHIN THE LINE. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE OUTCOME WAS RESOLVED; A NEW TUBING WAS USED. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22047524 ↗MalfunctionJan 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BLOOD LEAKED OUT OF THE INNER TUBE AND MIXED WITH THE FLUID IN THE OUTER TUBE AND CONTAMINATED THE LEVEL 1 AS SOME BLOOD WAS FOUND IN THE RESERVOIR. HAVE TRIED TROUBLESHOOTING WITH ANOTHER TUBING SET (USING RED FOOD DYE) TO SEE IF THE RED DYE ENDED UP IN THE RESERVOIR. IT DID NOT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18457121 ↗MalfunctionJan 5, 2023Break; Break
IT WAS REPORTED THAT THE CAREGIVER ATTEMPTED TO LOAD AND UTILIZE TUBING FOR THE DEVICE. SHORTLY AFTER SETUP AND BLOOD CONNECTED, THE CAREGIVER NOTICED THAT THE TUBING HAS SNAPPED JUST ABOVE THE FILTER. THIS INCIDENT DELAYED CARE DUE TO THE FACT THAT ADDITIONAL TUBING WAS NEEDED AND SET UP AGAIN. EVENTUALLY PATIENT RECEIVED TRANSFUSION. THERE WAS NO PATIENT HARM REPORTED, ALTHOUGH THE SIGNIFICANT DELAY IN TRANSFUSION COULD HAVE POTENTIALLY CAUSED ISSUES. PATIENT REQUIRED ADDITIONAL CRYSTALLOID BEFORE BLOOD COULD BE ADMINISTERED. PATIENT WAS STABILIZED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16108927 ↗MalfunctionAug 16, 2021Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION RECEIVED A SMITHS MEDICAL FLUID WARMING/LEVEL 1 TRAUMA FAST FLOW DISPOSABLES D-60HL WAS LEAKING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12328561 ↗MalfunctionAug 16, 2021Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION RECEIVED A SMITHS MEDICAL FLUID WARMING/LEVEL 1 TRAUMA FAST FLOW DISPOSABLES D-60HL WAS LEAKING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12328488 ↗
Other DEVICE, WARMING. BLOOD AND PLASMA devices
- Level 1 DI-60HLIcu Medical, Inc. · DEVICE, WARMING. BLOOD AND PLASMA1 death150 reports
- Level 1 DI-100Icu Medical, Inc. · DEVICE, WARMING. BLOOD AND PLASMA3 deaths131 reports
- Level 1 D-100Icu Medical, Inc. · DEVICE, WARMING. BLOOD AND PLASMA85 reports
- Level 1 DI-300Icu Medical, Inc. · DEVICE, WARMING. BLOOD AND PLASMA44 reports
- Level 1 D-300Icu Medical, Inc. · DEVICE, WARMING. BLOOD AND PLASMA16 reports
- Level 1 Y-INJIcu Medical, Inc. · DEVICE, WARMING. BLOOD AND PLASMA2 reports
- Level 1 PF-1Icu Medical, Inc. · DEVICE, WARMING. BLOOD AND PLASMA1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.