Model Number 806455 |
Device Problem
Mechanical Problem (1384)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Per the manufacturer subsidiary, the perfusionist found that the reservoir volume was increased even when the occluder was fully closed.It appeared that the plunger was not coming out completely when fully occluded.This complaint is related to (b)(4) / mfr#1828100-2020-00424.
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Event Description
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It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the occluder did not fully occlude.As mitigation, manual occlusion was done using forceps.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Manufacturer Narrative
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Updated blocks: d10 and h3.H3: 81 evaluation is in progress but not yet concluded.
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Manufacturer Narrative
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Per the user facility's product manager, the plunger on the occluder head would not fully come down so the a full occlusion was not happening.
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Event Description
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Additional information was received from the manufacturer's clinical specialist that the issue occurred during priming of the device.
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician (pst) did not observe any issues.A functional test was performed on the occluder and observed no water level change in the tubing over time.
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Manufacturer Narrative
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Updated block: h6 the reported complaint was confirmed based on a video that was sent in by the user but was unable to be duplicated during testing.The service repair technician (srt) could not duplicate the complaint.Testing was performed and the srt observed the occluder head to function as intended.The unit operated to the manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Search Alerts/Recalls
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