This complaint was reported by getinge's corporate medical affairs manager via an article in the 22nd annual scientific meeting, hfsa s119 / s120 journal of cardiac failure vol.24 no.8s august 2018.As follows: after nine (9) days on an unknown intra-aortic balloon pump (iabp), a patient with refractory unstable angina developed a sudden onset of abdominal pain and signs of peritonitis and leukocytosis.The intra-aortic balloon catheter (iabc) was via percutaneous axillary insertion and an abdominal ct scan was performed and showed pneumatosis coli with venous gas.An emergent right hemicolectomy was performed.Percutaneous axillary insertion of the iabc is off-label use per getinge's instruction for use (ifu).The article did not provide any information on whether the balloon pump in use at the time was a maquet/getinge intra-aortic balloon pump or allege a malfunction thereof of the involved iabp; however, the event site is a getinge account.A getinge service territory manager (stm) contacted the customer and was advised that no patient information or further event details was available.A separate report was submitted on the iabc suspected to be involved in this event under medwatch #2248146-2018-00650.
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