Description of Event or Problem · 1
NITROGLYCERIN DRIP STOPPED AND FLUID CONTIONUED TO FLOW DUE TO MALFUNCTION OF ROLLER CLAMP SEVERE HYPOTENSION, WAS REVIVED WITH IV FLUIDS AND REVERSE TRENDELENBERG POSITIONING. PATIENT HAD NO RESIDUAL EFFECTS FROM ADVERSE EVENT. ON EXAMINATION OF THE VENTED NITROGLYCERIN SET THE ROLLER CLAMP CLEARLY FAILED AND WAS THE CAUSE OF THE OVERDOSE OF IV NITROGLYCERIN TO THE PATIENT. MANUFACTURER'S QUALITY CONTROL DIVISION NOTIFIED AND DEVICE THAT CAUSED THE ADVERSE EVENT FORWARDED TO MANUFACTURER FOR FURTHER INVESTIGATION AND FOLLOW-UPDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT 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. 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: COMPONENT FAILURE, OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.