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 Problem Shock (2072)

Event Date 10/11/2018

Event Type  Injury  

Manufacturer Narrative

This incident occurred in (b)(6) and we are reporting this event since we consider the severity of the event is serious injury as the patient experienced shock and causal relationship between this device and the event could not be denied because the event happened during the immunoadsorption plasmapheresis therapy.We are unable to investigate since the actual used medical device was not returned to us and the lot number was unknown.The root cause could not be identified.The adverse event may have been caused by clinical condition of the patient.

Event Description

The female patient with primary disease of myasthenia gravis experienced following adverse event during immunoadsorption plasmapheresis treatment.The patient received the first immunoadsorption plasmapheresis therapy on (b)(6) 2018 and the second therapy on (b)(6) 2018 with no issue.On (b)(6) 2018, the third therapy was given to the patient.The patient blood pressure was between 110 and 120 mmhg and heart rate was 60 bpm before the therapy.34 minutes after the therapy was started, her blood pressure was decreased to 100 mmhg.41 minutes after the therapy was started, she complained of epigastric pain.Since the blood pressure was decreased to 58 mmhg and heart rate was also decreased to between 30 to 40 bpm, 300 ml of normal saline was administered.After the administration of normal saline, the patient blood pressure was increased to 100 mmhg temporarily, but it was decreased again to 70 mmhg and consciousness level was dropped.To treat the symptoms, oxygen therapy was administered at 1l/min.49 minutes after the treatment was started, the blood pressure was increased to 126 mmhg and level of consciousness was recovered.The blood was returned to the patient.

• 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: 8050026
• MDR Text Key: 126508463
• Report Number: 8010002-2018-00200
• 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: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2018
• 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: IMMUSORBA TR-350
• Patient Outcome(s): Congenital Anomaly; Hospitalization; Other; Required Intervention; Disability
• Patient Age: 83 YR
• Patient Weight: 49