PERFUSION SYSTEMS AFFINITY CP CENTRIFUGAL BLOOD PUMP; TUBING, PUMP, CARDIOPULMONARY BYPASS
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Model Number AP40 |
Device Problems
Obstruction of Flow (2423); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/08/2021 |
Event Type
Injury
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Manufacturer Narrative
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Conclusion: review of the complaint file determined the unit was not returned because the customer discarded the device, so unable to confirm the complaint and unable to determine root cause for the issue with no product returned.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that during use of this bio-console and external motor drive instrument the customer heard a noise and thought the ap40 pump decoupled.The external motor drive was on, but there was no forward flow.The nurses were hand cranking when the perfusionist arrived.The instrument was changed out with a backup and there was no resulting adverse patient effect.
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Search Alerts/Recalls
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