inforMED
MalfunctionMEA

ALARIS PC

Received Sep 19, 2012 · Event occurred Aug 10, 2012

Report 2759727 · MDR key 2759727

Device

Generic name

Pump, Infusion, Pca

Manufacturer

Cardinal Health

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Loss of Power

Patient

1 YR

  • Inadequate Pain Relief
  • Underdose

Narrative

Description of Event or Problem

PATIENT HAD IV FLUIDS WITH PCA (PATIENT CONTROLLED ANALGESIA) CONTINUOUS AND AN ANTIBIOTIC RUNNING. PATIENT STARTED HAVING INCREASED PAIN AND MOTHER OF THE PATIENT REQUESTED THAT THE NURSE CALL THE PHYSICIAN TO HAVE HIS PAIN MEDICATION INCREASED. NURSE OBTAINED THE ORDER FROM THE HEM/ONC TEAM TO INCREASE IT. WHEN TWO RN'S WENT INTO THE PATIENT'S ROOM TO CHANGE THE PCA SETTINGS THEY FOUND THAT THE VOLUME INFUSER BRAIN WAS ON AND THE FLUIDS WERE RUNNING ON THE RIGHT SIDE OF THE PUMP, BUT THE PCA AND PATIENT'S SYRINGE PUMP WITH THE ANTIBIOTIC WAS TURNED OFF. BOTH RN'S DETERMINED FROM THE HISTORY ON THE PUMP THAT IT HAD BEEN OFF FOR APPROXIMATELY 1 HOUR AND 45 MINUTES. WHEN ONE OF THE RN'S SQUEEZED THE BRAIN AND THE PCA PUMP TOGETHER, IT WOULD LIGHT UP. AS SOON AS THE OTHER RN WOULD LET OFF, IT WOULD SHUT OFF AGAIN. PHYSICIAN WAS NOTIFIED AND ORDER RECEIVED FOR ONE TIME BOLUS. WE HAVE HAD THIS TYPE OF ISSUE WITH THIS DEVICE PREVIOUSLY; HOWEVER, WE ARE NOT SEEING A TREND. THE PUMPS ARE CLEANED FIRST WITH ORGANOSOL AND THEN WITH CAVICIDE. STAFF THAT CLEANS THE EQUIPMENT USES A TOOTHBRUSH ON THE METAL CONNECTIONS TO ENSURE THAT THEY ARE CLEAN AND FREE FROM SCALE/DEPOSITS. THIS PARTICULAR PCA HAD A NEW BATTERY REPLACED IN THE SPRING AND HAS PASSED ALL OF ITS PREVENTATIVE MAINTENANCE CHECKS. THE MOST RECENT PREVENTATIVE MAINTENANCE CHECK ON THE PCA WAS PERFORMED APPROXIMATELY 3 MONTHS BEFORE THE EVENT. PER BIOMED, WE HAVE HAD NO TRENDS WITH DEVICE CONNECTIONS. BIOMED BELIEVES THAT THE DEVICE MAY NOT HAVE BEEN PLUGGED IN OR CONNECTED PROPERLY TO THE BRAIN. BIOMED STAFF WERE UNABLE TO REPRODUCE THE PROBLEM AND HAS RELEASED THE PCA UNIT BACK INTO USE.