MalfunctionOVQ

CLINIMACS

Received Mar 28, 2016 · Event occurred Feb 19, 2016

Report 5528825 · MDR key 5528825

Device

Generic name

Magnetic Cell Selection System For Cd34+ Cells From Hpc-apheresis Used In Treat

Manufacturer

Miltenyi Biotec

Model number

151-01

Product problems

Device Operates Differently Than Expected

Patient

Not reported

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

Narrative

Description of Event or Problem

DURING A CD34 CELL SELECTION ON THE CLINIMACS INSTRUMENT, THE PROCESS ENDED BEFORE ALL OF THE PRODUCT HAD BEEN SELECTED. IT IS UNKNOWN WHY THE PROCESS STOPPED, POSSIBLY DUE TO A CLOT, AIR BUBBLE, OR DEVICE FAILURE. NO CLOTS OR AIR BUBBLES WERE OBSERVED, SO IT IS POSSIBLE THAT THERE IS AN INSTRUMENT FAILURE. MANUFACTURER RESPONSE FOR CLINIMACS INSTRUMENT, CLINIMACS (PER SITE REPORTER): THE MANUFACTURER WAS CONTACTED ABOUT THIS ISSUE. NO RESPONSE HAS BEEN RECEIVED YET.