Description of Event or Problem · 1
PATIENT REMOVED ARTERIAL NEEDLE WHICH ALLOWED AIR TO ENTER EXTRA CORPOREAL CIRCUIT, WHEN THE COLUMN OF AIR REACHED THE AIR DETECTOR IT PASSED TO WITHIN 12 INCHES BEFORE THE AUDIBLE ALARM AND THE CLAMP ENGAGED. NO AIAR ENTERED THE PATIENT'S VENOUS SYSTEM. ALL ALARM FUNCTIONS HAD BEEN TESTED AND WERE IN GOOD WORKING ORDER PRIOR TO INITIATION OF PATIENT'S DIALYSISDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-DEC-91. 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, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MECHANICAL PROBLEM, NONE OR UNKNOWN, NONE OR UNKNOWN, OTHER. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, DEVICE TEMPORARILY REMOVED FROM SERVICE, INSERVICED BY BIOMEDICAL ENGINEERING DEPT. STAFF. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.