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

Model Number OP-05W

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

Patient Problems Shock (2072); No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2018

Event Type  Injury  

Manufacturer Narrative

This incident occurred in (b)(6) and is reported to fda according to the requirement.Op-05w is identical model to op-05w(a) marketed in us.The product of this event was not returned to the manufacturer and could not be analyzed.The lot number of the product was not reported, and we could not review the manufacturing and quality control records.According to the physician's comment, the physician considered that this event as life-threatening condition, "serious" and the causal relationship between this event and the plasmaflo op and/or immusorba tr could be ruled out because the patient's condition, dehydration lead to the event.We considered that this event as "serious" because the patient experienced shock and intravenous atropine treatment was performed to her.Also, we considered the causal relationship between the event and op could not be denied because the patient experienced "shock" during the treatment using op.The caution as to this event is not written in the package insert of op, we will continue to monitor the occurrence of these kinds of events.

Event Description

This case occurred in the facility of (b)(6).This patient had the immunoadsorption therapy using the medical device of plasmaflo op-o5w, which is used as plasma separator and is a similar product of plasmaflo op-05w(a) sold in us, and immusorba tr-350, which removes pathogenic substances by selective adsorption and is marketed in (b)(6).One hour and fifteen minutes after the start of the treatment, when 1080 ml of the plasma had been treated , the patient experienced shock with 69/43 mmhg of blood pressure and 25 times/min of pulse rate.Normal saline solution and atropine was given to her and then she recovered.Also, the 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, 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: 8721240
• MDR Text Key: 148823845
• Report Number: 8010002-2019-00100
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OP-05W
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ACH-SIGMA; IMMUSORBA TR-350
• Patient Outcome(s): Life Threatening
• Patient Age: 71 YR
• Patient Weight: 48