Cardiacassist inc.Manufactures the lifesparc pump.The incident occurred in the (b)(6), though the exact location and hospital is unknown, as it was not included in the elso clinical reports.As no details regarding the hospital, device or nature of the pump failure were included in the clinical report, additional investigation is not possible at this time.Due to elso confidentiality agreements with hospitals and livanova, it is not expected that further information will be provided on these incidents.However, if any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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