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

Model Number S-25

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

Patient Problems Dyspnea (1816); Fever (1858); Low Blood Pressure/ Hypotension (1914); Vomiting (2144)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

Doctor's comment: since the eosinophils were 50% range, the doctor completely suspected of allergies.Due to ablation and fever, antibiotics, antipyretics and warfarin were added.Since the medications keep being administered with tapering as of (b)(6) 2019, the doctor regards that the events were not allergy caused by taking medicine.Although the cause of the events could not be specified, but no problem was observed during the treatment of hd alone without lixelle.The patient is trying to send to hematologists while the eosinophils remain high.Manufacture's narrative: some medications have been described as anaphylactic shock as a side effect.In addition, after ablation, there was a state in which the patient's physical condition was not good even with hd alone, and the patient had a fever.It is considered that the anaphylactoid symptoms such as blood pressure drop at restart of lixelle might have occurred due to vagal reflex in a poor physical condition and due to increase in extracorporeal blood volume by lixelle, although we could not specify the cause of the events.

Event Description

Lixelle s-15 treatment during hemodialysis (hd) was introduced on (b)(6) 2017 without problems.Lixelle s-25, a larger size lixelle, started to use instead of s-15 on (b)(6) 2017 and was used successfully.The patient was transferred to another hospital for ablation on (b)(6) 2018 and started administration of warfarin.The first hd without lixelle after discharge on (b)(6) 2018 was performed.Although the patient felt a little sick, however he completed the hd to the end.The hd with lixelle s-25 was resumed on (b)(6) 2018.The blood pressure (bp) at the start of treatment was about 150 mmhg but dropped to about 90 mmhg.Wheezing, breathing difficulty and pallor of the face were observed.Since spo2 was 93%, oxygen inhalation was started at 2 l, however the patient caused nausea and vomiting.It was decided that the treatment was discontinued in 40 minutes from the start.Hd with lixelle s-25 was conducted again on (b)(6) 2018.The patient had a fever of 38 degrees at the start.Flu test was negative.After taking antipyretics, the treatment was started.The blood pressure was 120 mmhg at the start of treatment.One hour later, he complained of abdominal discomfort.Although the blood pressure was maintained from120 mmhg to 130 mmhg, saline was infused to the patient.Pulse 98, spo2 97%, hr99.Since the patient caused wheezing, oxygen inhalation was started at 2 l, but it was not subsided.The patient vomited 3 times even if the oxygen inhalation was raised by 3 l.It was decided that the treatment was difficult to continue and stopped, and then the patient was hospitalized.Qb: 220 ml / min, treatment hours: 4.5, anticoagulant: heparin, one shot 750 iu, continuation rate 1000 iu/hr.

• 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: 8423409
• MDR Text Key: 138895867
• Report Number: 3002808904-2019-00007
• Device Sequence Number: 1
• Product Code: PDI
• UDI-Device Identifier: 14993478020225
• UDI-Public: 14993478020225
• 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: 02/21/2019

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
• Device Operator: Health Professional
• Device Model Number: S-25
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/14/2019
• 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): Hospitalization