MAUDE Adverse Event Report: KANEKA CORPORATION LIXELLE BETA2-MICROGLOBULIN APHERESIS COLUMN; BETA 2-MICROGLOBULIN APHERESIS COLUMN

Model Number	S-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)
Date of Event	04/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The possible causes of the loss of consciousness in this case are as follows.It was speculated that the combination of the product increased the extracorporeal circulation volume and water removal, resulting in a hypobolemic tendency in the latter half of the treatment, which was also affected by the efficacy of the antihypertensive agent taken on the morning of the treatment, leading to a decrease in blood pressure and loss of consciousness.
Event or Problem Description
The patient history is hypertension, hyperlipidemia.Ormesartan 5 mg and amlodipine 5 mg were taken orally on the morning of treatment.During dialysis, it remained around bp120, and sometimes it was 90-150.When the staff returned to the bedside to return blood, the patient lost consciousness (syncope), and the patient did not respond to the call with the eyes open.The patient's lower limbs were lifted and blood was returned.After 1-2 minutes, the eyes were fluttered and the call was responded.At the end of blood return, 80 bp, no abnormal oxygen value.

• Brand Name: LIXELLE BETA2-MICROGLOBULIN APHERESIS COLUMN
• Common Device Name: BETA 2-MICROGLOBULIN APHERESIS COLUMN
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka, osaka 530-8 288; JA 530-8288
• MDR Report Key: 9999541
• Report Number: 3002808904-2020-00007
• Device Sequence Number: 2078425
• Product Code: PDI
• UDI-Device Identifier: 14993478020218
• UDI-Public: 14993478020218
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: H130001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2020

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
• Operator of Device: Health Professional
• Device Model Number: S-15
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 04/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 35