Catalog Number 12320 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Lot number and manufacture date are not available at this time. investigation is in process and a follow up report will be provided.
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Event Description
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The customer reported that during a continuous mononuclear cell collection (cmnc) procedure on a spectra optia device the collect line was "clotted".The operator changed out the blood warmer tubing because there was a faulty luer connection and air was coming into the set.The operator confirmed that there was color in the collect port in the centrifuge, and that the interface was unstable.The operator lowered the ac ratio down to 8 and adjusted the cp as needed.The operator consulted a physician and continued the procedure.Per the customer, there was no evidence of clumping in the connector.Customer information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.
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Manufacturer Narrative
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Investigation: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Investigation is in process and a follow up report will be provided.
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Event Description
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The customer reported that during a continuous mononuclear cell collection (cmnc) procedure on a spectra optia device the collect line was "clotted".The operator changed out the blood warmer tubing because there was a faulty luer connection and air was coming into the set.The operator confirmed that there was color in the collect port in the centrifuge, and that the interface was unstable.The operator lowered the ac ratio down to 8 and adjusted the cp as needed.The operator consulted a physician and continued the procedure.Per the customer, there was no evidence of clumping in the connector.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.
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Search Alerts/Recalls
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