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

Model Number OP-05D

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

Patient Problem Bradycardia (1751)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

The medical device ((b)(4)) was not returned and could not be analyzed.No abnormalities were found in the manufacturing and shipping records of the lot.We evaluated bradycardia and cardiopulmonary arrest as serious event.The cause of the onset might be the effect of cholinesterase inhibitors, but the op-08d cannot be ruled out because it occurred during immunoadsorption.In addition, the cause of the onset cannot be identified considering the combined use of medical devices other than the op-08d.Physician's comment.Patients were taking cholinesterase inhibitors, so the vagal reflex (bradycardia) was likely to progress.It is possible that immunoadsorption therapy stimulated the vagal reflex.It is described in e.Precautions of the instruction for use as follows.If any problem such as the following occurs during treatment with the plasmaflo¿ (b)(4), immediately ensure the safety of the patient and take appropriate measures, such as discontinuation of the treatment or replacement of the plasmaflo¿ (b)(4), in accordance with the directions of the responsible physician.Bradycardia and cardiopulmonary arrest are currently not mentioned in warnings of the instruction for use, but there is no increase in frequency observed, and we will continue to monitor the occurrence of similar events carefully.

Event Description

This incident occurred in (b)(6).The patient had immunoadsorption therapy using the medical device of plasmaflo op-05d, which is used as plasma separator and is a similar product to plasmaflo(b)(4) marketed in us, and immusorba (b)(4) which adsorbes substances in separated plasma and is not marketed in us.The patient's primary disease is unknown, but the patient is always taking cholinesterase inhibitors.(b)(6) immunoadsorption therapy was performed using (b)(4).Bradycardia (about 30 bpm) occurred when 1 liter of plasma was treated after the start of treatment.The patient went into cardiopulmonary arrest, but underwent a cardiac massage and his heartbeat resumed.Immunoadsorption therapy was discontinued.(b)(6) the patient had moved from the icu to the general ward.

Manufacturer Narrative

The medical device (op-08d) was not returned and could not be analyzed.No abnormalities were found in the manufacturing and shipping records of the lot.We evaluated bradycardia and cardiopulmonary arrest as serious event.The cause of the onset might be the effect of cholinesterase inhibitors, but the op-08d cannot be ruled out because it occurred during immunoadsorption.In addition, the cause of the onset cannot be identified considering the combined use of medical devices other than the op-08d.Physician's comment.Patients were taking cholinesterase inhibitors, so the vagal reflex (bradycardia) was likely to progress.It is possible that immunoadsorption therapy stimulated the vagal reflex.It is described in e.Precautions of the instruction for use as follows.If any problem such as the following occurs during treatment with the plasmaflo¿ op-05w(a), immediately ensure the safety of the patient and take appropriate measures, such as discontinuation of the treatment or replacement of the plasmaflo¿ op-05w(a), in accordance with the directions of the responsible physician.Bradycardia and cardiopulmonary arrest are currently not mentioned in warnings of the instruction for use, but there is no increase in frequency observed, and we will continue to monitor the occurrence of similar events carefully.

Event Description

This incident occurred in (b)(6).The patient had immunoadsorption therapy using the medical device of plasmaflo op-05d, which is used as plasma separator and is a similar product to plasmaflo op-05w(a) marketed in us, and immusorba tr-350(l which adsorbes substances in separated plasma and is not marketed in us.The patient's primary disease is unknown, but the patient is always taking cholinesterase inhibitors.October 13, immunoadsorption therapy was performed using (b)(4).Bradycardia (about 30 bpm) occurred when 1 liter of plasma was treated after the start of treatment.The patient went into cardiopulmonary arrest, but underwent a cardiac massage and his heartbeat resumed.Immunoadsorption therapy was discontinued.October 18, the patient had moved from the icu to the general ward.

• 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: naomi kagami ; 1-1-2 yurakucho; chiyoda-ku; tokyo, 100-0-006 ; JA 100-0006
• MDR Report Key: 12757926
• MDR Text Key: 285191619
• Report Number: 8010002-2021-00070
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: OP-05D
• Device Lot Number: 3L4F4P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2021
• 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): Required Intervention