inforMED
MalfunctionBSB

QINFLOW BLOOD AND FLUID WARMER QIF-01 BASE UNIT (BU)

Received Aug 15, 2018 · Event occurred Jun 14, 2018

Report 7784766 · MDR key 7784766

Device

Generic name

Warmer, Blood, Non-electromagnetic Radiation

Model number

01

Catalog number

QPORT1100U

Product problems

  • Device Displays Incorrect Message

Patient

21535 DA

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DURING AIR FLIGHT TRANSPORT OF A CRITICAL TRAUMA PATIENT, PATIENT WAS RECEIVING FIRST UNIT OF BLOOD VIA BLOOD FLUID/WARMER UNIT. A CHANGE IN FLOW MESSAGE DID DISPLAY, BUT WENT AWAY. THE FIRST UNIT OF BLOOD WAS NEARING COMPLETION, AND THE RN HOOKED A SYRINGE TO THE TUBING AND PULLED REMAINING BLOOD FROM BAG TO PUSH INTO THE LINE. THE FLUID/BLOOD WARMER UNIT ALARMED "MALFUNCTION." THE RN TURNED OFF THE UNIT, TOOK BATTERY OUT, TURNED BACK ON YET THE BLOOD WARMER CONTINUED TO SHOW "MALFUNCTION." THE FLUID/BLOOD WARMER UNIT WAS TAKEN OUT OF SERVICE. THE ONCOMING CREW TROUBLESHOT THE MACHINE AND IT WORKED FOR THEM WITHOUT ISSUE. TEAM INVESTIGATING CONSIDERED LIKELY CAUSE FOR THE "MALFUNCTION" MESSAGE WAS THE ATTACHMENT OF SYRINGE TO LINE AND PULLING FLUID/BLOOD INTO SYRINGE. THIS MAY HAVE CAUSED NEGATIVE BACK PRESSURE IN DU, AND THEREFORE CAUSE A "MALFUNCTION" MESSAGE. THIS FACILITY WILL FOLLOW UP WITH THE VENDOR. BIOMEDICAL ENGINEERING EVALUATED THE UNIT AND ALSO WERE UNABLE TO DUPLICATE REPORTED PROBLEM. UNIT POWERED UP AND PASSED MANUFACTURER TESTING PROCEDURE - NO PROBLEMS FOUND.