Description of Event or Problem · 1
THE EMERGENCY DEARTMENT RN PROGRAMMED THE LARGE VOLUME INFUSION PUMP FOR A BLOOD TRANSFUSION (ONE UNIT OF WHOLE BLOOD. THE NURSE REPORTS SHE PROGRAMMED THE DEVICE TO DELIVER AT 150CC PER HOUR. AT THE ONE HOUR MARK, THE PUMP HAD DELIVERED ALL OF THE TRANSFUSION, WHICH IS APPROXIMATELY 500CC. THE RN REPORTS THE ONLY ALARM THAT SOUNDED WAS THAT THE INFUSION WAS COMPLETE, WHICH WAS ONE HOUR AFTER SHE HAD STARTED IT. UPON INSPECTION OF THE PUMP, THE RN FOUND A SMALL STICKY-NOTE THAT SAID "BROKEN" ON THE BACK OF THE MACHINE. THE PATIENT WAS NOT HARMED BY THIS EVENT --LUNGS WERE CLEAR AND THERE WAS NO EDEMA AFTER THE TRANSFUSION. THE PHYSICIAN WAS INFORMED OF THE EVENT. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE EVENT, NOR WAS HOSPITALIZATION EXTENDED. NO INFORMATION IS KNOWN ABOUT THE PATIENT THE PUMP HAD BEEN USED ON PREVIOUSLY; NOR IS ANY INFORMATION KNOWN AS TO WHAT EXACTLY WAS 'BROKEN' FOR THIS DEVICE. BIOMED WAS CONTACTED AND HAS RETURNED THE PUMP TO THE MANUFACTURER FOR INVESTIGATION/ANALYSIS. BIOMED ALSO IS IN THE PROCESS OF REVIEWING OUR CURRENT TAGGING SYSTEM (WHICH DOES NOT INCLUDE STICKY-NOTES OR THE SOLE DESCRIPTION OF 'BROKEN') AND PROVIDING EDUCATION TO STAFF FOR MARKING & REMOVING EQUIPMENT REQUIRING SERVICE.PER BIOMED: WHEN BIOMED CAME TO PICK UP THE PUMP, AN ERROR MESSAGE WAS DISPLAYED ON THE SCREEN, ERROR #185: "PROX OCCL A AT STARTUP." THIS INCIDENT WAS REPORTED TO HOSPIRA 5 DAYS LATER, 800.441.4100 (B) (4). BIOMED REQUESTED THAT HOSPIRA SEND A REP TO THE FACILITY TO DOWNLOAD THE DEVICE, BUT WAS INFORMED THAT "THE OPTION TO HAVE THE FIELD SERVICE ENGINEER (FSE) COME TO YOUR FACILITY IS NOT AVAILABLE FOR THIS CASE." TIME DEVICE WAS PROGRAMMED AND INFUSION STARTED: ACCORDING TO THE DEVICE'S ALARM HISTORY LOG, IT APPEARS THAT THE IV WAS RUNNING FOR APPROXIMATELY ONE HOUR THE DAY BEFORE BIOMED WAS NOTIFIED. (SEE THE TRANSCRIPTION OF THE ALARM LOG, BELOW.) ====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE DEVICE WAS NOT PROPERLY LABELED AS NEEDING REPAIRS AND WAS NOT REMOVED FROM THE SERVICE AREA ONCE REPAIRS WERE IDENTIFIED.IT IS UNKNOWN WHY THE DEVICE DELIVERED 100% OF THE VOLUME IN 1 HOUR.====================== MANUFACTURER RESPONSE FOR LARGE VOLUME INFUSER, ABBOTT PLUM A+======================THE MANUFACTURER WAS NOTIFIED ON 7/27 AND THE DEVICE HAS BEEN RETURNED TO THEM FOR INVESTIGATION/ANALYSIS. WE ARE AWAITING THEIR FINDINGS. THE MANUFACTURER WAS UNABLE TO SEND A REP TO OUR FACILITY TO DOWNLOAD THE DEVICE ON-SITE.