ULTRAFILTER HECHINGEN
Received Oct 3, 2024 · Event occurred Sep 6, 2024
Report 9611369-2024-00175 · MDR key 20359533
Device
Generic name
Subsystem, Water Purification
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
NI
Lot number
NI
Product problems
- Break
- Fluid/Blood Leak
- Break
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT A U9000 ULTRAFILTER WAS OBSERVED TO BE BROKEN AND LEAKED DURING AN AK96 MACHINE DISINFECTION PROCESS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
H11: THE DEVICE WAS EVALUATED ON-SITE BY A QUALIFIED TECHNICIAN. VISUAL INSPECTION SHOWED THE ULTRAFILTER TO BE BROKEN AND LEAKING. THE DEVICE WAS REPLACED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.