inforMED
MalfunctionFKQ

CENTRISOL ACID CONCENTRATE, CA2.5 K3.0, 1 GALLON

Received Aug 2, 2024

Report MW5157962 · MDR key 19905436

Device

Generic name

System, Dialysate Delivery, Central Multiple Patient

Manufacturer

Medivators Inc

Catalog number

SB-353

Lot number

598341

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

THE DIALYSATE SOLUTIONS ARE IN JUGS. THE JUGS THAT CONTAIN 2 GRAMS OF POTASSIUM AND 3 GRAMS OF POTASSIUM HAVE THE SAME COLOR AND STYLE OF LABEL EXCEPT FOR THE 2 AND THE 3. ATTACHED YOU WILL FIND A PICTURE OF THE TWO JUGS OF ACID SOLUTION WITH THE SAME LABEL EXCEPT FOR THE K AMOUNT ADDED. YOU MAY USE MY NAME AND ADDRESS. SUGGESTION WOULD BE TO HAVE DIFFERENT COLOR LABELS TO DIFFERENTIATE THE 2 GM VERSUS 3 GM JUGS. (B)(6). SUBMISSION ID: (B)(4). REFERENCE REPORT: MW5157961.