inforMED
MalfunctionFJD

EZ-CHEK

Received Jun 16, 2023 · Event occurred Apr 22, 2023

Report 17142603 · MDR key 17142603

Device

Generic name

Detector, Leak, Blood

Model number

K100-0114

Catalog number

K100-0114

Lot number

101055

Product problems

  • Fluid/Blood Leak
  • Protective Measures Problem

Patient

15695 DA · Female

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

Narrative

Description of Event or Problem

THE CRRT DIALYSIS MACHINE AT THE PATIENT'S BEDSIDE ALARMED FOR A BLOOD LEAK, ALARM # INDICATED A MECHANICAL ERROR - "LEAK" CHECK FOR PRESENCE OF BLOOD AS A PRECAUTION. BLOOD LEAK TEST STRIP READ POSITIVE FOR BLOOD BUT SUSPECTED A FALSE POSITIVE SO IT WAS CHECKED AGAIN BY JUST TESTING IT USING PLAIN WATER. THE STRIPS CONTINUED TO TEST POSITIVE. STRIPS WERE TAKEN OUT OF USE AND REPORTED TO LEADERSHIP TEAM. MANUFACTURER RESPONSE FOR DETECTOR, LEAK, BLOOD, EZ-CHEK (PER SITE REPORTER). PLAN IS TO MAKE MANUFACTURE AWARE, STILL PENDING.