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

Model Number S-15

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

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 10/28/2019

Event Type  Injury  

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 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
• Type of Device: BETA2-MICROGLOBULIN APHERESIS COLUMN
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 530-8 288; JA 530-8288
• Manufacturer Contact: yoshiyuki kitamura ; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 530-8-288 ; JA 530-8288
• MDR Report Key: 9303205
• MDR Text Key: 184905829
• Report Number: 3002808904-2019-00030
• 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: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

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