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

Model Number S-15

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 04/16/2020

Event Type  Injury  

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 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
• Type of Device: BETA 2-MICROGLOBULIN APHERESIS COLUMN
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka, osaka 530-8 288; JA 530-8288
• Manufacturer Contact: tamiji fujimoto ; 2-3-18; nakanoshima, kita-ku; osaka, osaka 530-8-288 ; JA 530-8288
• MDR Report Key: 9999541
• MDR Text Key: 190617079
• Report Number: 3002808904-2020-00007
• Device Sequence Number: 1
• Product Code: PDI
• UDI-Device Identifier: 14993478020218
• UDI-Public: 14993478020218
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H130001
• 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: 04/17/2020

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
• Device Operator: Health Professional
• Device Model Number: S-15
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2020
• Initial Date FDA Received: 04/26/2020
• 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
• Patient Outcome(s): Other
• Patient Weight: 35