inforMED
MalfunctionPWH

CADD

Received Aug 12, 2020 · Event occurred Jul 1, 2020

Report 3012307300-2020-08082 · MDR key 10396028

Device

Model number

21-7609-24

Product problems

  • Fluid/Blood Leak
  • Fluid/Blood Leak

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

INFORMATION WAS RECEIVED INDICATING THAT WHEN USING THE CADD CASSETTE RESERVOIRS - FLOW STOP THE CUSTOMER NOTICED IT BROKE AND THE MEDICAL FLUID LEAKED FROM IT. THERE WERE NO ADVERSE EVENTS REPORTED.