inforMED
InjuryLNR

CELLEX PHOTOPHERESIS PROCEDURAL KIT

Received Apr 23, 2019 · Event occurred Mar 5, 2019

Report MW5086090 · MDR key 8544925

Device

Generic name

System, Photopheresis, Extracorporeal

Lot number

G375

Product problems

  • Fluid/Blood Leak
  • Explosion

Patient

39 YR

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

Narrative

Description of Event or Problem

DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT, AFTER APPROX 227 ML OF WHOLE BLOOD PROCESSED, THE CENTRIFUGE BOWL EXPLODED WITHIN THE CENTRIFUGE CHAMBER. THE PT LINES WERE IMMEDIATELY CLAMPED, AND THE PROCEDURE WAS ABORTED. BLOOD ESCAPED THE CENTRIFUGE CHAMBER ONTO THE PUMP DECK. THE INSTRUMENT WAS PULLED FROM SERVICE AND WAS CLEANED AND REPAIRED BY THE MFR'S CONTRACTED SERVICE COMPANY. (B)(4).