MalfunctionLGZ
LEVEL 1 LOW FLOW HOTLINE DISPOSABLE SET
Received Jul 7, 2026 · Event occurred Jun 1, 2026
Report 3012307300-2026-07138 · MDR key 25739115
Device
Generic name
Warmer, Thermal, Infusion Fluid
Catalog number
L-70
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT BLOOD LEAKED FROM THE CONNECTION BETWEEN THE HOTLINE HEATING TUBE AND THE HOTLINE MAIN UNIT DURING PRIMING. THERE WERE NO PATIENT INVOLVEMENT AND NO PATIENT HARM.
Additional Manufacturer Narrative
B3: DATE OF EVENT UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.