The device history records (dhr) of the device concerned was reviewed.The production lot, to which the device concerned belongs, passed all in-process inspections test.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.Our view the facility has not reported any defects and malfunction in the product, and we determine that it is due to the patient's condition and usage.However, since health hazards to patients have occurred, and the causal relationship between health hazards and the product cannot be completely ruled out, we will submit mdr (30 days).
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On (b)(6) 2020, patient received treatment with liposorberla-15 system.The treatment was completed.At 4:00pm the patient was admitted to the hospital for anasarca with worsening aki exacerbated by dehydration in the setting of elevated cyclosporine levels.The site noted that the sae is possibly related to the treatment and that the device did not malfunction.On 11/23/2020, the site reported the sae, classified the adverse event as serious, and noted that the patient was still hospitalized.On 11/30/2020 user facility reported la-15 system lot and serial numbers.They reported that the adverse event has ended on (b)(6) 2020 and that the patient would be continuing treatment with the liposorber system.User facility reported actions taken to treat adverse event as the following medications; cyclosporine held, fluconazole held, lasix oral and iv, and 25% albumin.
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