inforMED
MalfunctionGIO

CARE-FILL CAPILLARY TUBES

Received May 31, 2024 · Event occurred Feb 14, 2024

Report MW5155659 · MDR key 19447163

Device

Generic name

Tube, Collection, Capillary Blood

Lot number

23156-1

Patient

1 MO · Female

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

Narrative

Description of Event or Problem

THIS RN WAS PERFORMING A CAPILLARY BLOOD GAS ON AN INFANT. I OBTAINED MY SAMPLE WITH THE CARE-FILL CAPILLARY TUBES AND THE EPOC MACHINE READ "IQC FAILURE- INSUFFICIENT AMOUNT..." I INSERTED A NEW TEST CARD AND REPEATED THE PROCESS. I INFORMED THE CHARGE NURSE OF THE ISSUE. ON MY SECOND ATTEMPT WITH THE SAME EPOC MACHINE, I RECEIVED THE SAME ERROR MESSAGE. AT THIS POINT I GRABBED ANOTHER EPOC MACHINE AND THE CHARGE NURSE ATTEMPTED A CAPILLARY BLOOD GAS. THE SAME ERROR MESSAGE APPEARED, SO AT THIS POINT WE GRABBED A NEW BOX OF CAPILLARY TUBES. THIS TIME THE TEST WAS COMPLETED AND SUCCESSFUL. SEE LOT NUMBER AND INFO BELOW. CAPILLARY TUBES IN BOX AT CHARGE NURSE DESK IN NICU. THE POCT TEAM TOOK THE DEVICE AND PERFORMED TESTING ON IT WITHOUT ANY ERRORS. EXPIRATION DATES WERE CHECKED AND ALL ITEMS WERE WITHIN EXPIRATION AND VALID FOR USE. ULTIMATELY, THE APPARENT CAUSE OF THE ISSUE IS THE CAPILLARY TUBES IN USE WERE "STICKY" WHICH LEAD TO SUB-OPTIMAL SAMPLE QUALITY FOR INJECTIONS. THAT BOX OF CAPILLARY TUBES WERE DISPOSED AND A NEW BOX IS BEING UTILIZED. NO ISSUES THUS FAR. REFERENCE REPORTS MW5155657, MW5155658.