Catalog Number 10220 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problem
Overdose (1988)
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Event Date 05/14/2015 |
Event Type
malfunction
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Manufacturer Narrative
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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 the inlet roller clamp was left open, resulting in an extra 800ml of saline being delivered to the patient.Patient's information and condition are not known at this time.The disposable kit is not available for return, because it was discarded by the customer.
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Manufacturer Narrative
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Investigation is in process.A follow-up report will be provided.
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Event Description
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No medical intervention was required for this event and no additional follow-up visit wasnecessary.The patient is reported in stable condition.
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Manufacturer Narrative
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Investigation: a review of the device history record for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer's facility staff has been trained on multiple occasions and continue to receive ongoing support.The operator is experienced with the product/device.Root cause: based on the investigation and information provided by the customer, the root cause of the patient's hypervolemia was that the saline clamp was left open during a portion of the procedure.
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Search Alerts/Recalls
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