Description of Event or Problem · 1
ON MARCH 21, 1992 THE PUMP WAS BEING USED ON A CONTINUOUS INFUSION WITH PCA CAPABILITY. THE PUMP WAS SET TO INFUSE THE MEDICATION OVER FORTEEN HOURS BUT WAS NOTED TO HAVE BEEN COMPLETELY INFUSED WITHIN FOUR HOURS AND FORTY-FIVE MINUTES. THE PUMP WAS IMMEDIATELY TAKEN OUT OF SERVICE AND SEQUESTERED. ARRANGEMENTS HAVE BEEN MADE WITH ABBOTT SALES REP. TO HAVE AN ON SITE ASSESSMENT OF THE PUMP WITH THE N.Y.U MEDICAL CENTER CLINICAL ENGINEERING DIRECTOR. THE PUMP WUILL THEN BE SENT BACK TO ABBOTT FOR FURTHER INVESTIGATIONINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.