Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Injury (2348)
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Event Date 05/21/2020 |
Event Type
Injury
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Manufacturer Narrative
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The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided.There was no reported malfunction of the involved iabp, and the serial number was not provided to us.However, upon investigation, we were advised that the therapy was terminated prior to removing the balloon, thus the iabp was stopped prior to removing the balloon.In addition, the perfusionist stated that the iabp was not in the or when they were addressing the situation.No further investigation is required.Not returned to manufacturer.
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Event Description
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It was reported after intra-aortic balloon pump (iabp) therapy ended, the clinical team removed the balloon catheter from the patient artery and tore the femoral artery.They emergently moved the patient to the operating room to control the situation and complete removal of the balloon.After removing the balloon catheter, the team is describing that the tip of the balloon catheter was melted.The balloon catheter was not replaced.Indication for use of the iabp therapy was to wean the patient from cardiopulmonary bypass.No patient death occurred.Please refer to mfg report number 2248146-2020-00282 for information on the involved balloon catheter.
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Manufacturer Narrative
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Corrected data: pma/510(k)# from: unknown to: k112372.
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Event Description
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It was reported after intra-aortic balloon pump (iabp) therapy ended, the clinical team removed the balloon catheter from the patient artery and tore the femoral artery.They emergently moved the patient to the operating room to control the situation and complete removal of the balloon.After removing the balloon catheter, the team is describing that the tip of the balloon catheter was melted.The balloon catheter was not replaced.Indication for use of the iabp therapy was to wean the patient from cardiopulmonary bypass.No patient death occurred.Please refer to mfg report number 2248146-2020-00282 for information on the involved balloon catheter.
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Event Description
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It was reported after intra-aortic balloon pump (iabp) therapy ended, the clinical team removed the balloon catheter from the patient artery and tore the femoral artery.They emergently moved the patient to the operating room to control the situation and complete removal of the balloon.After removing the balloon catheter, the team is describing that the tip of the balloon catheter was melted.The balloon catheter was not replaced.Indication for use of the iabp therapy was to wean the patient from cardiopulmonary bypass.No patient death occurred.Please refer to mfg report number 2248146-2020-00282 for information on the involved balloon catheter.
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Search Alerts/Recalls
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