Model Number 12320 |
Device Problems
Use of Device Problem (1670); Insufficient Information (3190)
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Patient Problem
Hypervolemia (2664)
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Event Date 09/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Lot number, manufacture and expiry date 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 called at 29 minutes into a continuous mononuclear cell (cmnc) collection procedure and stated they had the 'interface taking too long to establish' alarm.They stated that the plasma was collected but it doesn't look like it is 100ml + 40 ml of heparin and acd-a.They were instructed by the call center confirm if the saline rollers were closed.The customer noted they had the inlet saline roller open.The customer sent a picture of the plasma, which appears to look more like saline in the collect bag.Patient total blood volume (tbv): 3362 ml, saline bag 1000ml; at time of call there were approximately 200 ml left in the saline bag.The customer started the procedure over to follow the prompts appropriately.Patient is stable and at 114% tbv.Patient information is not available at this time.The disposable set is not available for return for evaluation.
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Manufacturer Narrative
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Investigation: the customer provided a picture to aid in the investigation.The pictures confirmed that the contents in the collect bag contained mostly saline and anticoagulant as observed by the customer.The picture also showed a blood warmer tubing attached to the device.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.Correction: 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 called at 29 minutes into a continuous mononuclear cell (cmnc) collection procedure and stated they had the 'interface taking too long to establish' alarm.They stated that the plasma was collected but it doesn't look like it is 100ml + 40 ml of heparin and acd-a.They were instructed by the call center confirm if the saline rollers were closed.The customer noted they had the inlet saline roller open.The customer sent a picture of the plasma, which appears to look more like saline in the collect bag.Patient total blood volume (tbv): 3362 ml, saline bag 1000ml; at time of call there were approximately 200 ml left in the saline bag.The customer started the procedure over to follow the prompts appropriately.Patient is stable and at 114% tbv.The customer failed to respond to multiple attempts to obtain essential information like patient information.The disposable set is not available for return for evaluation.
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Search Alerts/Recalls
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