Model Number 12220 |
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 05/30/2023 |
Event Type
malfunction
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Event Description
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The customer reported that they were performing a therapeutic plasma exchange (tpe) using a spectra optia device on a patient with high triglycerides levels.The customer noticed that there appeared to be some hemolysis in the plasma line.Per follow up from the customers doctor the procedure was discontinued as the patient has underlaying issues.When asked by terumo bct support to pause the device and check the fluids, the customer stated that the saline bag was 0.45 % instead of 0.9%.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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Manufacturer Narrative
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Lot number and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.10.Investigation: a photograph of the interface through the viewport was provided to tbct clinical support which confirmed the plasma in the connector was red and there was hemolysis.Additionally, a photograph showing an in-date 1l bag of 0.45% usp saline was provided.Lot number and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.
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Event Description
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The customer reported that they were performing a therapeutic plasma exchange (tpe) using a spectra optia device on a patient with high triglycerides levels.The customer noticed that there appeared to be some hemolysis in the plasma line.Per follow up from the customers doctor the procedure was discontinued as the patient has underlaying issues.When asked by terumo bct support to pause the device and check the fluids, the customer stated that the saline bag was 0.45 % instead of 0.9%.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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Manufacturer Narrative
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Investigation: a photograph of the interface through the viewport was provided to tbct clinical support which confirmed the plasma in the connector was red and there was hemolysis.Additionally, a photograph showing an in-date 1l bag of 0.45% usp saline was provided.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 reported that they were performing a therapeutic plasma exchange (tpe) using a spectra optia device on a patient with high triglycerides levels.The customer noticed that there appeared to be some hemolysis in the plasma line.Per follow up from the customers doctor the procedure was discontinued as the patient has underlaying issues.When asked by terumo bct support to pause the device and check the fluids, the customer stated that the saline bag was 0.45 % instead of 0.9%.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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Manufacturer Narrative
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This report is being filed to provide additional information in h.10.Investigation: a photograph of the interface through the viewport was provided to tbct clinical support which confirmed the plasma in the connector was red and there was hemolysis.Additionally, a photograph showing an in-date 1l bag of 0.45% usp saline was provided.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: * patient's underlying disease state.Patient's medication and/or medical treatment.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 rbc¿s 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.Hemolysis due to incorrect saline concentration used resulting in a hypotonic environment to the rbcs.
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Event Description
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The customer reported that they were performing a therapeutic plasma exchange (tpe) using a spectra optia device on a patient with high triglycerides levels.The customer noticed that there appeared to be some hemolysis in the plasma line.Per follow up from the customers doctor the procedure was discontinued as the patient has underlaying issues.When asked by terumo bct support to pause the device and check the fluids, the customer stated that the saline bag was 0.45 % instead of 0.9%.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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