64 Chapter 3 Severe adverse event case selection During the total innovation project, 5736 MLC-aCTGs were performed. Seven cases (0.1%) with a potential SAE were retrospectively reported. Table 4 provides an overview of the potential SAEs with a case description, whether it was attributable to the aCTG-innovation project, and, if applicable, the causes of an SAE. After a critical incident analysis by the multidisciplinary expert team, five potential SAEs were excluded from further analysis because of a causality score of zero (no evidence of being related to clinical management). One case was assessed with a causality score of three (causality with clinical management not likely, but a close call). The experts identified one SAE related to human factors, i.e., incorrect aCTG-assessment and subsequent fetal death (causality score of six; clear evidence for causality with clinical management). The experts judged the SAE to be avoidable (avoidability score of six: clear evidence for avoidability). In consequence of the critical incident analysis, the experts recommended two potential prevention strategies for this SAE: ensuring sufficient exposure in assessing aCTGs, and considering only performing MLC-aCTGs from 32 weeks onwards. Furthermore, they underlined the importance of performing MLC-aCTG-assessment by two professionals and aCTG training to improve competence.
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