Catalog Number 0684-00-0575 |
Device Problem
Suction Problem (2170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Occupation: supply chain mgr.The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id #: (b)(4).
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Event Description
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It was reported that the customer could not aspirate two intra-aortic balloons (iab).It was noted that the iabs were able to be flushed.After removal, they tried to pull back on the iabs in saline and couldn¿t pull back.Ultimately, they ended up using a 40cc iab instead.There was no patient harm or adverse event reported.This report is for the 2nd iab involved in this event.A separate report has been submitted for the 1st iab under mfg report number 2248146-2024-00074.
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Manufacturer Narrative
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The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).
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Event Description
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N/a.
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Search Alerts/Recalls
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