Description of Event or Problem · 1
MORPHINE WAS ADMINISTERED VIA PCA PUMP WITH SETTINGS AS ORDERED: 0.0 MG. BASAL RATE, 0.5 MG. DOSE, 10 MIN LOCK OUT, 0.0 MG. LOADING DOSE. AFTER 2 HOURS 32 MINUTES PATIENT HAD RECEIVED 23.3 MG. WITH ONE INJECTION AND TWO ATTEMPTS, RESULTING IN RESPIRATORY DEPRESSION WHICH REQUIRED NARCAN ADMINISTRATION TO CORRECT CONDITION. RESUSCITATION WAS SUCCESSFUL. PATIENT WAS DISMISSED 12/20/92 ALERT, NEUROLOGICALLY INTACT. IN EVALUATING THE DEVICE AND EVENT, IT APPEARS THAT THE INCIDENT FALLS WITHIN ONE OF THE CONDITIONS LISTED IN THE MAY 22, 1992 HEALTH DEVICE ALERTS. THE INHOUSE INVESTIGATION AND THIRD PARTY REVEALED NO MALFUNCTION. NOTE: ITEM 34 OF TEST FORM - OTHER DEVICES IN USE AT TIME OF EVENT (1) INFUSION PUMP/CONTROLLERDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE NOT SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-NOV-91. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS NOT AVAILABLE.NO 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: NONE OR UNKNOWN, NONE OR UNKNOWN. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED, NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION, NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, DEVICE TEMPORARILY REMOVED FROM SERVICE, USER EDUCATION PROVIDED. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.