MalfunctionLNR

CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT

Received May 23, 2023 · Event occurred Apr 21, 2023

Report MW5117785 · MDR key 16993852

Device

Generic name

System, Photopheresis, Extracorporeal

Manufacturer

Mallinckrodt Hospital Products Inc.

Lot number

L307

Product problems

Burst Container or Vessel

Patient

70 YR · Male

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

STARTED PHOTOPHERESIS PROCEDURE, GOT THROUGH MACHINE PRIME, HOOKED UP PT, GOT THROUGH PURGING PROCESS, WENT TO TURN UP THE COLLECT SPEED AS IN ANY PROCEDURE AND SUDDENLY PHOTOPHERESIS BOWL EXPLODED. PT IMMEDIATELY CLAMPED AND SAFE, NEW MACHINE LOADED WITH NEW KIT, PROCEDURE RAN SMOOTHLY. THE MALFUNCTIONING KIT DISPOSED OF IN BIOHAZARD BAG, MACHINE CLEANED UP AND SENT BIOMED FOR DIAGNOSTICS AND REPAIR. THERAKOS MANUFACTURER NOTIFIED; PICTURES SENT THERAKOS AND BIOMED. (B)(6).