inforMED
MalfunctionKPO

RENAL PURE LIQUID ACID CONCENTRATE

Received May 27, 2022

Report MW5109992 · MDR key 14548231

Device

Generic name

Dialysate Concentrate For Hemodialysis (liquid Or Powder)

Manufacturer

Rockwell Medical

Product problems

  • Device Markings/Labelling Problem

Patient

Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

THE ACID COMPONENT OF THE DIALYSATE COMES IN TWO DIFFERENT STRENGTHS. HOWEVER, BOTH BOTTLES ARE EXACTLY THE SAME WITH THE EXACT SAME LABEL THE ONLY DIFFERENCE BEING THE STRENGTH PRINTED IN SMALL. PRINT IN THE BOTTOM RIGHT HAND CORNER.