Model Number 10220 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Hemolysis (1886)
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Event Date 04/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This report is being filed to provide additional information in d.4, h.6 and h.10.Investigation: the customer submitted a photograph of the interface through the viewport to tbct clinical support which confirmed the plasma in the connector was red and there was hemolysis.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, a follow-up report will be provided.
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Event Description
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The customer called because at the beginning of the run the system continued to detect cells in the plasma line in the centrifuge.The customer did a blood prime with a hct of 65 and the patient hct of 36.Customer raised the patient's hct to 50.The patient has transverse myelitis and he said the interface was high.The procedure was paused and the physician was notified.Dr.Redwine wanted to continue with the procedure.Patient information is unknown at this time.The patient was reported as stable and did not allege any medical intervention.The collection set is not available for return because it was discarded by the customer.
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Event Description
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The customer called because at the beginning of a therapeutic plasma exchange (tpe) to inform that the system continued to detect cells in the plasma line in the centrifuge.The customer did a blood prime with a hematocrit (hct) of 65% and the patient hct of 36%.The customer raised the patient's hct to 50.The patient has transverse myelitis and he said the interface was high.The procedure was paused and the physician was notified.The doctor wanted to continue with the procedure.Clinical support talked him through pressing disable on the alarm screen.He was trying to continue with the procedure but at this time he was having inlet pressure alarms.Clinical support suggested he lower the inlet flow rate.The patient catheter is in the femoral, they have already tried switching the line.After multiple follow-ups no patient, disposables or additional details were obtained.The patient was reported as stable and did not require any medical intervention.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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This report is being filed to provide additional information in b.5, h.6 and h.10.Investigation: the customer submitted a photograph of the interface through the viewport to tbct clinical support which confirmed the plasma in the connector was red and there was hemolysis.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.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause for hemolysis could not be determined but it is likely due to one or a combination of the possible causes listed below: hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.Hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.Hemolysis due to pinched return line resulting in rbcs exposed to pressure drop in return line.Hemolysis due to pinched inlet line resulting in rbcs exposed to pressure drop in inlet line.The residual total risk is determined to be low.Hemolysis due to an occlusion in the tubing resulting in rbcs exposed to a pressure drop.
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Search Alerts/Recalls
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