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); High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Discomfort (2330); Loss of consciousness (2418)
Date of Event	01/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As possible causes for arrhythmia during the treatment with lixelle, in general, situations as follows are considered: hypokalemia or hyperkalemia, occurrence accidentally based on the past history of arrhythmia, and/or decrease in trough level of digoxin, anti-arrhythmic drug, due to adsorption to the lixelle during the treatment.The lixelle is confirmed in clinical investigations that the use of lixelle is unlikely to influence on the trough level of potassium.The patient's blood chemistry for potassium before and after the occurrence of the arrhythmia was not available.It is confirmed that the patient does not have history of arrhythmia and accordingly does not take digoxin.Accordingly, possible causes for the arrhythmia resulted in lost consciousness during the treatment with lixelle on this patient is not clear.However, we cannot completely exclude the relevance of the use of lixelle to the event reported, and we determine the case as mdr reportable.
Event or Problem Description
This device, lixelle beta2-microglobulin apheresis column (lixelle), was introduced to a (b)(6) years of age female patient on chronic hemodialysis for 27 years for the treatment of her dialysis related amyloidosis (dra).The reported event occurred on the very first treatment with lixelle.For this treatment, a hemodialysis module was changed to fx-cordiax 140 (fresenius) from renak ps 1.6 (kawasumi) in order to reduce the total priming volume.The patient showed mood discomfort 10 minutes before the end of the treatment, was recognized arrhythmia, and then lost consciousness.The patient was given i.V.300ml of physiological saline and then, she became responding to voice call in 8 minutes after her lost consciousness, and her arrhythmia ceased.Additional 200ml of physiological saline was given and her mood discomfort disappeared in 30 minutes after her lost consciousness.Since then, the patient is continued on hemodialysis without lixelle by using renak ps 1.6.

• 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: 7269107
• Report Number: 3002808904-2017-00015
• Device Sequence Number: 1343272
• 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): 01/18/2018

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 Expiration Date: 05/28/2019
• Device Model Number: S-15
• Device Catalogue Number: N/A
• Device Lot Number: BMP1506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/13/2018
• 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: Life Threatening
• Patient Age: 69 YR
• Patient Weight: 46