It was reported that, after the use of the product, an under delivery of the medication was observed.There was a discrepancy in the remaining amount (an under delivery), and the customer changed the disposable to another new one.At that time, the remaining volume displayed on the screen was 14ml and the administered (infused) volume being 235ml.However, when the customer checked the cassette at the pharmacy, the actual remaining volume was 52ml.The physician commented that the cause of death was due to the patient's primary illness, and not due to the defect in the product.
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A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.
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