ULTRAFILTER HECHINGEN
Received May 21, 2025 · Event occurred Apr 29, 2025
Report 9611369-2025-00075 · MDR key 22062638
Device
Generic name
Subsystem, Water Purification
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
114604
Lot number
4-1805-H-01
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 ULTRAFILTER U9000 "JUST AFTER INSTALLATION" IN AN AK98 MACHINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: H6, H11 H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOS DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED LEAKAGE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE WAS NOT DETERMINED AS NO FURTHER OR ACTUAL SAMPLE TESTING COULD BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.