CRIT-LINE®
Received Jul 21, 2022 · Event occurred Jun 24, 2022
Report 15074307 · MDR key 15074307
Device
Generic name
Accessories, Blood Circuit, Hemodialysis
Manufacturer
Fresenius Usa, Inc.Model number
CL10041021Catalog number
CL10041021
Lot number
21KR01001
Product problems
- Break
- Fluid/Blood Leak
Patient
26280 DA · Male
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
SENSOR BROKE APART WHILE THE PATIENT WAS ON THE HD MACHINE CAUSING A BLOOD LEAK. HAD WE NOT NOTICED IMMEDIATELY AND STOPPED THE BLOOD PUMP, PATIENT WOULD HAVE MAJOR BLOOD LOSS AS THIS WAS LEAK IN THE CIRCUIT WITH A BLOOD PUMP AT 400 ML/MIN RUNNING. MINOR BLOOD LOSS TO PATIENT. THE FOLLOWING DAY, ANOTHER SENSOR WAS FOUND NOT TO BE BONDED TOGETHER PROPERLY- CAUGHT PRIOR TO USE.
Description of Event or Problem
SENSOR BROKE APART WHILE THE PATIENT WAS ON THE HD MACHINE CAUSING A BLOOD LEAK. HAD WE NOT NOTICED IMMEDIATELY AND STOPPED THE BLOOD PUMP, PATIENT WOULD HAVE MAJOR BLOOD LOSS AS THIS WAS LEAK IN THE CIRCUIT WITH A BLOOD PUMP AT 400 ML/MIN RUNNING. MINOR BLOOD LOSS TO PATIENT. THE FOLLOWING DAY, ANOTHER SENSOR WAS FOUND NOT TO BE BONDED TOGETHER PROPERLY- CAUGHT PRIOR TO USE.