There was no reported malfunction of the iabp unit in question, and customer has not requested getinge to evaluate the unit.Additionally, the iabp model and serial number was not provided to us.However, information has been requested, and if provided, a supplemental report will be submitted.
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Customer reported that post intra-aortic balloon pump (iabp) therapy they met resistance when removing the intra aortic balloon catheter (iabc).The customer reported that they "slightly enlarged the incision and when removing the catheter they noted a clot in the iabc".The pump model was not reported; however, the customer reported that there were no issues during therapy with the iabp, thus no reported malfunction of the iabp.The patient's injury is not attributed to the iabp.Refer to mfg report number 2248146-2020-00422 for information of the involved balloon catheter.
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