Description of Event or Problem · 1
THE DEVICE IN QUESTION WAS DELIVERING TPN AND LIPIDS TO A NEONATE AND IS REPORTED TO HAVE DELIVERED A DANGEROUSLY HIGH LEVEL OF TPN DURING AN HOUR AND A HALF PERIOD. THE TPN SOLUTION WAS BEING ADMINISTERED THROUGH A AT A RATE OF 3.7 ML/HR, COINCIDENTAL WITH LUPID ADMINISTRATION THROUGH CHANNEL B.AT 11:00 AM THE STATUS OF BOTH INFUSIONS WAS ALSO NOTED TO BE APPROPRIATE. AT NO TIME DURING THE MORNING SHIFT WERE THE SETTINGS ON EITHER CHANNEL ALTERED. AT 12:30 CHANNEL A WAS NOTED TO BE INDICATING "EMPTY BAG" AND THE CORRESPONDING BURRETTE WAS FOUND TO BE EMPTY. AT THIS TIME THE PUMP CONTROL PANEL WAS NOTED TO INDICATE; A VOLUME INFUSED-ML" OF 89; "VOLUME LIMIT-ML" WAS 8888; AND "RATE-ML/HR" WAS 8888. CHANNEL B WAS FOUND TO BE OPERATING NORMALLY.OTHER APPARATUS CLINICALLY IN USE AT THE SAME TIME THE INCIDENT OCCURRED WERE: AN INFRASONICS INFANT STAR INCUBATOR, A NELLCOR PULSE OXIMETER, AN AIR-SHIELDS ATHENA PHYSIOLOGIC MONITOR, AND AN OHIO INCUBATORDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JUL-92. SERVICE PROVIDED BY: INDEPENDENT SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: DESIGN - HUMAN FACTORS, CENTRAL PROCESSING UNIT/OPERATING SYSTEM FAILURE/BUG. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.