MalfunctionJRS

UF FILTER

Received Oct 11, 2018 · Event occurred Sep 25, 2018

Report 7995181 · MDR key 7995181

Device

Generic name

Uf Housing Header Cap

Manufacturer

Unknown

Model number

UNK

Catalog number

UNK

Lot number

UNK

Product problems

Material Deformation
No Flow

Patient

Not reported

No Known Impact Or Consequence To Patient
No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

THE UF FILTER HEAD FOR THE RO LOOP PLUMBED FOR CENTRAL BICARBONATE SYSTEM WAS MOLDED INCORRECTLY, SO THERE WAS NO FLOW TO THE INLET SIDE OF THE HOUSING HEAD. AN ADDITIONAL UF FILTER PLUMBED IN PARALLEL WITH THE DEFECTIVE DEVICE PREVENTED IMMEDIATE RECOGNITION OF DEVICE FAILURE.