Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.H3 other text : device was not returned to manufacturing facility.
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It was reported that the pump "did not infuse blood as programmed, never had any error alarms, after 75 minutes the volume infused looked correct but the bag was full." this was reported to bd representatives during their site visit.There was patient involvement but unknown outcome.
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