ULTRAFILTER HECHINGEN

Description of Event or Problem

IT WAS REPORTED THAT A U9000 ULTRAFILTER IN AN AK 96 MACHINE WAS FOUND TO BE "FAULTY" DURING HEMODIALYSIS THERAPY. THE MACHINE WAS ALLEGED TO HAVE "TOO MUCH DEHYDRATION" DURING THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS: (B)(6), 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.

Additional Manufacturer Narrative

CORRECTION, G3: DATE RECEIVED BY MFR: THE INITIAL MDR G3 DATE WAS INADVERTENTLY SUBMITTED AS 11/14/2024; HOWEVER, THE CORRECT DATE IS 11/25/2024. ADDITIONAL INFORMATION: B5: UPON FOLLOW UP IT WAS REPORTED THE FILTER WAS REPLACED. H11: IT WAS REPORTED THAT A NON-BAXTER TECHNICIAN EVALUATED THE DEVICE AND REPORTED THE FILTER WAS LEAKING AND THE DEVICE WAS DISCARDED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.