Model Number 10310 |
Device Problems
Use of Device Problem (1670); Insufficient Information (3190); Device Handling Problem (3265)
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Patient Problem
Hypervolemia (2664)
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Event Date 02/01/2023 |
Event Type
malfunction
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Event Description
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The customer reported the continuous mononuclear cell collection (cmnc) is still establishing interface after 25 min.The operator entered a hct of 36% from 1/12/23 and only checked the lines to make sure they were not obstructed.Customer support suggested to lower the hct down by 3% and wait 3-5 min.If the interface still wasn't about half of the connector it was suggested to lower the hct another 3%.The customer called back after adjusting the hct down by 8% and said the interface was still in the same position.A picture was sent and it was maybe about 1/4th of the connector.It was asked if the saline line roller clamps were open.The operator realized the red roller clamp was open and was on the 2nd 500 ml bag.The operator said she was checked off to do this procedure.Customer support explained she shouldn't have to change out the saline bag for the procedure.The hct has been diluted and this is why the interface has not come up.The operator reported there was about 50 mls left in the 2nd bag.It was estimated the 657 ml of ns used.Customer support suggested she lower hct down by 6% which is now at 22%.Patient information and outcome are not available 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: the customer did not respond to multiple requests for lot number.Therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Retraining was not completed since the customer failed to respond to multiple attempts to contact them.Root cause: a root cause assessment was performed for the unintended saline bolus to the patient.Based on the customer's statements, the operator failed to follow the screen prompts to fully close the inlet saline roller clamp at the end of saline prime divert.
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Event Description
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The customer reported the continuous mononuclear cell collection (cmnc) is still establishing interface after 25 min.The operator entered a hct of 36% from 1/12/23 and only checked the lines to make sure they were not obstructed.Customer support suggested to lower the hct down by 3% and wait 3-5 min.If the interface still wasn't about half of the connector it was suggested to lower the hct another 3%.The customer called back after adjusting the hct down by 8% and said the interface was still in the same position.A picture was sent and it was maybe about 1/4th of the connector.It was asked if the saline line roller clamps were open.The operator realized the red roller clamp was open and was on the 2nd 500 ml bag.The operator said she was checked off to do this procedure.Customer support explained she shouldn't have to change out the saline bag for the procedure.The hct has been diluted and this is why the interface has not come up.The operator reported there was about 50 mls left in the 2nd bag.It was estimated the 657 ml of ns used.Customer support suggested she lower hct down by 6% which is now at 22%.After multiple follow-up attempts, the customer did not provide patient information and outcome.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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