Description of Event or Problem · 1
PT ARRIVED IN CRITICAL CARE WITH ANESTHESIOLOGIST. PT PLACED ON VENTILATOR AND LINES CONNECTED WITH CASSETTES IN PLACE (NIPRIAL/POTASSIUM). PT STABLE FOR FIRST 20 MINS, HAVING SOME PJC'S. BEGAN HAVING IDIOVENTRICULAR RHYTHM. MEDICAL INTERVENTION INITIATED, RHYTHM DETERIORATED. CPR STARTED AND PT TAKEN BACK TO SURGERY EMERGENTLY. IN SURGERY POTASSIUM LEVEL FOUND TO BE 9.0. POTASSIUM CASSETTE FOUND SLIGHTLY DISENGAGED, NO ALARM INDICATING THAT CASSETTE WAS DISENGAGED. APPARENLY POTASSIUM WAS FREE FLOWING INTO PT. PT POTASSIUM LEVEL WAS RESTORED TO 4.7 AND READMITTED TO CRITICAL CARE.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JUL-93. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS 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, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - INADEQUATE, MECHANICAL PROBLEM, FAIL-SAFE SYSTEMS. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, INSERVICED BY OTHER FACILITY STAFF. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.