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

Model Number OP-08W

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

Patient Problem Renal Disease, End Stage (2039)

Event Date 03/27/2019

Event Type  Injury  

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, and is used as plasma separator.We reviewed manufacturing records, quality records of lot# mh5p61.As a result, no abnormality was found in records.No similar event using this lot# mh5p61 was reported globally.Physician considered that this event was serious adverse event of "hemolysis", and the causal relationship between this event and plasmaflo op could not be denied.We could not obtain detail information of this event, according to physician's comment, we considered that this event was serious, and that the causal relationship between plasmaflo op and this event could not be denied because the adverse event occurred during the treatment with op-08w.Hemolysis is described in the package insert of plasmaflo op (i.Preface, e.Precautions): 12.Hemolysis is an adverse reaction that can occur if the tmp increases above 100mmhg (13.3kpa).13.Monitor the patient constantly during treatment with the plasmaflo op-05w(a).In the event of any of the following during treatment, immediately ensure the safety of the patient and take appropriate measures in accordance with the directions of the responsible physician.Presence of hemoglobin in separated plasma, due to hemolysis.We will carefully continue to monitor and to be vigilant for the trend of occurrence of this kind of adverse events.

Event Description

This case occurred in (b)(6).A patient's underlying disease was uraemia.The double filtration plasmapheresis (dfpp) treatment was required to be performed in order to reduce the patient's antibodies before his kidney-transplant surgery.Just after the start of the treatment of dfpp using plasmaflo op-08w used as plasma separator, which is similar product of plasmaflo op-05w(a) marketed in us, the bright red liquid was observed in the separated plasma.The medical staffs judged that the possibility of the patient's hemolysis reaction was suspected, his treatment was stopped.

• 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
• Manufacturer (Section G): ASAHI KASEI MEDICAL MT CORP.; oita works; 2111-2 oaza sato; oita-shi, oita 870-0 396; JA 870-0396
• Manufacturer Contact: akitake yamashita ; 1-1-2 yurakucho, chiyoda-ku; tokyo 100-0-006 ; JA 100-0006
• MDR Report Key: 8643805
• MDR Text Key: 146224894
• Report Number: 8010002-2019-00080
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P820033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: OP-08W
• Device Catalogue Number: N/A
• Device Lot Number: MH5P61
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR