Updated fields: b4,d9,g3,g6,h2,h3,h4,h6(type of investigation, investigation findings, component codes, investigation conclusions), h10.Additional fields: e1(event site state: (b)(6)).It was reported that the cardiosave intra-aortic balloon pump (iabp) had internal communication error.There was no patient involvement and no patient harm reported.A getinge field service engineer fse was dispatched to the site to evaluate the unit.On investigation fill assembly and pim assy had failed fault occurred at start of usage and another balloon pump was used instead.Unit repaired & parts replaced as listed below.Complete cardiosave pm to factory specifications.Device passed all functional and safety tests according to factory specifications.Device was returned to customer and cleared for clinical use.
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