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

Model Number	S-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Doctor's comment since arrhythmias sometimes occurred, doctor do not believe that there is a causal relationship between arrhythmias and lixelle treatment.In the future, lixelle treatment will continue while observing the patient's condition.Inferred cause increased extracorporeal circulation volume due to the use of lixelle caused blood pressure drop and tachycardia, which may have caused arrhythmia during treatment, but the patient has had arrhythmia in the past.The cause is unknown.
Event or Problem Description
The patient was originally hypertensive and occasionally developed arrhythmias.The blood pressure during dialysis treatment was in the 150 mmhg range, but after the start of lixelle s-15 treatment, it dropped to the 70 mmhg range, and the pulse increased from 70 to 120.Because an arrhythmia developed, a defibrillation procedure was performed.There was also general pain due to decreased blood pressure.The patient was treated with lixelle once 8 years ago, and tachycardia occurred and the treatment was stopped.

• Brand Name: LIXELLE BETA2-MICROGLOBULIN APHERESIS COLUMN
• Common Device Name: BETA2-MICROGLOBULIN APHERESIS COLUMN
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 530-8 288; JA 530-8288
• MDR Report Key: 9303205
• Report Number: 3002808904-2019-00030
• Device Sequence Number: 11263204
• 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): 11/06/2019

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: 11/06/2019
• Initial Report FDA Received Date: 11/11/2019
• 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 Age: 63 YR
• Patient Weight: 54