Model Number 0998-00-0800-53 |
Device Problem
Device Contamination with Body Fluid (2317)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/30/2021 |
Event Type
malfunction
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Event Description
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It was reported that during patient use the cardiosave intra-aortic balloon pump (iabp) had a blood back due to blood entering the catheter tubing.There was no harm or injury to the patient and no adverse event was reported.
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Manufacturer Narrative
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Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.This report is being submitted as the result of a retrospective review conducted in capa (b)(4).
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Manufacturer Narrative
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Corrected fields: h6 (health effect ¿ clinical code).It was reported that during patient use the cardiosave intra-aortic balloon pump (iabp) had a blood back due to blood entering the catheter tubing.There was no harm or injury to the patient and no adverse event was reported.There was no information regarding service and no technical information is provided.Hence the complaint will be closed and will be reopened upon new information arrival.H3 other text : no update regarding unit repair.
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Event Description
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N/a.
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Search Alerts/Recalls
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