title: [Rare problem with the insertion of a Supreme™ laryngeal mask airway device. Case of the trimester].
abstract: A breast tumor was resected under general anesthesia. After induction, the airway was managed with a Supreme™ laryngeal mask airway device. The insertion of the laryngeal mask airway device, the insertion of the orogastric tube through the drain tube, as well as the mechanical ventilation, were very difficult from the beginning. On removing the laryngeal mask airway device to solve the problem, it was observed that the drain tube was broken, and the orogastric tube had passed into the anterior, laryngeal part of the device through the split. It was later found out that the laryngeal mask airway device, as well as the whole manufacturing batch, had suffered a design modification: the cuff was constructed with a softer material without reinforcement in the tip, and the drain tube had a heat-sealing defect that facilitated the break. The incident was reported to the local supplier and the manufacturer, and the defective batch of laryngeal mask airway devices was recalled. The incident was also reported to other hospitals via SENSAR, to warn other users of the potential dangers of the design modification in the Supreme™ laryngeal mask airway.
mesh_terms: D000402:Airway Obstruction / Q000209:etiology*; D000768:Anesthesia, General / Q000295:instrumentation; D001943:Breast Neoplasms / Q000601:surgery; D004867:Equipment Design; D004868:Equipment Failure; D019544:Equipment Failure Analysis; D005260:Female; D006801:Humans; D007441:Intubation, Gastrointestinal / Q000009:adverse effects* / Q000295:instrumentation; D017214:Laryngeal Masks / Q000009:adverse effects*; D008408:Mastectomy; D008875:Middle Aged; D012121:Respiration, Artificial; D012308:Risk Management / Q000458:organization & administration
keywords: Anestesia; Anesthesia; Análisis de fallos de equipamiento; Equipment failure analysis; Laryngeal masks; Mascarilla laríngea; Patient safety; Seguridad del paciente