PERFUSION SYSTEMS AFFINITY CP CENTRIFUGAL BLOOD PUMP; TUBING, PUMP, CARDIOPULMONARY BYPASS
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Model Number AP40 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation summary: visual inspection shows evidence of a loose piece of white fm inside the tubing that is attached to the ap40 pump.Additional visual analysis shows the ap40 impeller is broken.Reason for return was confirmed medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Medtronic received information that prior to use of a custom pack, the customer reported that there was some sort of broken plastic piece inside the tubing and could not tell if there was more broken pieces.The pump and oxygenator were replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the sterile barrier was still sealed when fm was identified.Medtronic received additional information that the impeller of the ap40 centrifugal pump in the custom tubing pack was damaged.
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Search Alerts/Recalls
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