MalfunctionFIP
ULTRAFILTER HECHINGEN
Received Mar 20, 2025 · Event occurred Mar 3, 2025
Report 9611369-2025-00037 · MDR key 21657463
Device
Generic name
Subsystem, Water Purification
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
NI
Lot number
NI
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM AN UNSPECIFIED LOCATION OF AN ULTRAFILTER U9000 DURING SETUP WITH AN AK 98 MACHINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
E1: INITIAL REPORTER ADDRESS: (B)(6) HOSPITAL. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.