Catalog Number 10220 |
Device Problems
Coagulation in Device or Device Ingredient (1096); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/16/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Device lot #, manufacture date, and expiry are not available at this time.Investigation: during customer follow-up, the physician stated that 800mg of calcium chloride (cacl2) per 100ml of saline is infused at 75ml/h and after reviewing the patient's chart, it was determined that the patient's calcium usage may have contributed to the clotting that they observed during the procedure.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 near the end of red blood cell exchange (rbcx) procedure, they have seen clotting in the tubing set.The customer stated that the clotting was observed 'in the circuits' late into the procedure.During this procedure, they had increased the hematocrit 5% points from the starting procedure.They did not adjust the anti-coagulant ratio when clots were observed, instead, they flushed the access line.Patient information and outcome are not available at this time.The disposable 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 customer stated that they began implementing a saline bolus on the return line using a stop cock to control the flow and noticed that implementation has helped to resolve the clotting they were observing.Investigation is in process.A follow-up report will be provided.
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Event Description
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The operator at the customer's site stated that clotting was noticed throughout the circuit and they pulled clots from the inlet and return tubing lines.They ended the procedure prior to the clots being returned to the patient.The patient is reported in stable condition.
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Manufacturer Narrative
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This report is being filed to provide additional information.Investigation: during customer follow-up, the customer stated that she was only aware of one patient in particular that clotting occurred during a procedure.She reviewed the patient's chart and noted that the patient underwent the procedures on (b)(6) 2016.However, she was unsure of the procedural dates when the clotting issues occurred.Investigation is in process.A follow-up report will be provided.
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Manufacturer Narrative
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Investigation: during customer follow-up, the customer stated that they have been adding saline boluses to their rbcx procedures and noticed that the clotting issues in the disposable set have virtually been eliminated and they have not had any clotting issues.The run data file (rdf) was analyzed for this event.Interface images determined that there were no indications of clumping in the channel.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Root cause:the root cause for this particular issue is unknown at this time.Possible causes include but are not limited to:- patient physiology- patient access problem- ac ratio issues- need for the addition of saline during the procedure.
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Search Alerts/Recalls
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