D
Patient 1
RESPIRATORY THERAPIST WENT TO USE HELL WARMER ON PED PATIENT AND THE BAG EXPLODED FROM THE TOP OF THE BAG AND CONTENTS SPLASHED INTO EMPLOYEES EYES. A CERIFIED NURSE PRACTITIONER'S HAD THE CONTENTS SPLASH ON TO HER HAIR AND FORHEAD DID NOT BURN HER, BUT HER CLOTHES DID RECEIVE HOLES IN THEM. OTHER WITNESS WAS NOT INJURYED.I THE RISK MANAGER COULD NOT FINE DTHE PACKAGE IT WAS DESTROYED, NOT SAVED ALL OTHER HEEL WARMERS THROUGH OUT THE HOSPITAL REMOVED ON 11/30/93.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 2.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: VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - INADEQUATE, LABELING - DIFFICULT TO READ/SEE, LABELING - ON PACKAGE, TELEMETRY FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT, DEVICE DISCARDED - UNABLE TO FOLLOW-UP, DEVICE UNAVAILABLE FOR FOLLOW-UP INVESTIGATION EXAMINATION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED, DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS DESTROYED/DISPOSED OF.