Medex Hi-Flo 3 Gang, 4-Way Manifold w/MLL
Received Jul 31, 2026 · Event occurred Jul 8, 2026
Report 1526863-2026-00160 · MDR key 50101319
Device
Generic name
Stopcock, I.v. Set
Manufacturer
Icu Medical Healthcare Manufacturing S.a. De C.vCatalog number
MX4345LM
Product problems
- Crack
Patient
Unknown
- Low Blood Pressure/ Hypotension
Narrative
Description of Event or Problem
It was reported that during therapy, the manifold was cracked and begin to leak. This issue which resulted in critically ill and unstable decompensating, also BP drastically dropping and nearly coding for the patient, including possible exposure to the drug. The manifold was replaced and Epinephrine was administered to stabilize the patient. There was patient involvement and harm was reported.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress. A supplemental MDR will be filled as necessary in accordance with 21 CFR 803.56 when additional reportable information becomes available.