MAUDE Adverse Event Report: ASAHI KASEI MEDICAL CO., LTD. PLASMAFLO OP; PLASMA SEPARATOR

Model Number OP-05W(A)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Liver Damage/Dysfunction (1954); No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2018

Event Type  Death  

Manufacturer Narrative

This incident occurred in (b)(6) and is reported to fda according to the requirement.Plasmaflo op-08w is similar product of plasmaflo op-05w(a) marketed in us.The used product and information of lot number were not available because the product was disposed in the healthcare facility.Consequently, the root cause of the event could not be identified as only the insufficient information was available.Plasmaflo op is used as plasma separator and plasma component is further separated by plasorba brs, which was concomitantly used for the patients.Pulmonary alveolar hemorrhage which caused the patient's death is not described in the instructions for use (ifu) of plasmaflo op.Physician considered that this patient's death was mainly caused by the aggravation of patient's complication of serious liver failure, pulmonary alveolar haemorrhage.However, since the adverse event occurred during the treatment, the causal relationship between the patient's pulmonary alveolar haemorrhage and plasmaflo op could not be denied.We considered that the pulmonary alveolar haemorrhage was serious, and that the causal relationship between plasmaflo op and the pulmonary alveolar haemorrhaget could not be denied because the adverse event occurred during the treatment with op-08w and plasorba brs.This case was obtained from the doctor's inquiry to us.As the doctor is reluctant to our further investigation, the follow-up investigation like the patient's underlying disease and the cause of the this event is not possible.Although this adverse event is not written in the ifu of op, as this case is the first time to receive as op, so we will carefully continue to monitor and to be vigilant for the trend of occurrence of this kind of adverse events.

Event Description

A patient was in the condition of postoperative hepatic failure in (b)(6).The patient's bilirubin value began to increase around the second day after the operation, although the laboratory data of the patient's coagulation factor was in the lower level, this patient's apheresis treatment with plasmflo op-08w, used as plasma separator and similar product of op-05w(a) sold in us, and plasorba brs, absorptive removal column of bilirubin and bile acid, to absorb bilirubin was started.The situation about the first treatment was unknown.In the end of (b)(6) 2018, the patient developed the pulmonary alveolar hemorrhage in the second treatment with op-08w and plasorba brs, and died after its treatment.The detail information about the medical treatment of the adverse event was unknown.

Manufacturer Narrative

We became aware of two erratum of the year 2018.Date of this report and date received by manufacturer in our initial report during our internal check.The correct year is 2019.We are submitting this follow-up report to correct erratum as follows: date of this report: 15/02/2019.Date received by manufacturer: 15/02/2019.

• Brand Name: PLASMAFLO OP
• Type of Device: PLASMA SEPARATOR
• Manufacturer (Section D): ASAHI KASEI MEDICAL CO., LTD.; 1-1-2 yurakucho; chiyoda-ku; tokyo 100-0 006; JA 100-0006
• MDR Report Key: 8385341
• MDR Text Key: 137654688
• Report Number: 8010002-2019-00010
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• PMA/PMN Number: P820033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OP-05W(A)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PLASORBA BRS; PLASORBA BRS
• Patient Outcome(s): Death