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 Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045); Low Oxygen Saturation (2477)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that upon the initiation of the treatment with the lixelle, the dialyzer used was switched to fb-130pb with a larger surface area from fb-110pb (nipro).She complained pains in the chest to the back with chills in the 1st treatment (5 days before the day of this reported event) with the lixelle and had respiratory distress with chills in the 2nd (2 days before).On her show up for the treatment on the day of the reported event, she had a feeling of fatigue, with the body temperature: 37.5 degrees, blood pressure: 110/45 mmhg, pulse: 75/min, spo2: 95%, weight gain from the treatment: 2.6kg.No history of allergy.No particular adverse event has ever occurred in hemodialysis procedures in the past.However, she appealed strong indefinite complaints, anxiety and self-assertion, and was difficult to accept treatment policies.In the past several months, anorexia had continued, and there were signs of heart failure due to pleural effusion based on the chest radiograph and increase in ctr.We speculate possible causes of this reported event as follows: due to the increase in the total priming volume by the change in the dialyzer with a larger surface area and adding the lixelle, the patient was in the situation where hypotension was likely to occur more than before.After starting the hemodialysis with adding the lixelle, the targeted dehydration seemed not have achieved and the amount of body fluid gradually increased, which might have resulted in worsening in congestion of the lungs and/or pulmonary edema to develop chest pain and dyspnea.The patient's physical conditions on the day of the reported event was deteriorated and it worsened the situation.In conclusion, we determine this reported adverse event was caused not by the devices used including the lixelle but by the patient's physical conditions and intolerability to the procedure.

Event Description

The subject was a (b)(6)-year-old female on chronic hemodialysis (3 times a week) for 40 years.The lixelle s-15, beta2-microglobulin adsorption column, was introduced for the treatment of her dialysis related amyloidosis (dra).The lixelle is used to add in the hemodialysis circuit usually before a dialyzer in every hemodialysis procedure.During the 3rd treatment with the lixelle on (b)(6) 2018, she developed dyspnea with hypotension in 40 minutes after initiating the treatment.Oxygen supply was started (spo2 was 83%) and the dehydration on the hemodialysis was stopped.Although the oxygen supply was continued her respiratory distress persisted.In about 135 minutes after the initiation of the treatment, her bp had risen to 140mmhg, spo2 had reached 99%, the hydration procedure was resumed.Her respiratory distress persisted, her body temperature raised to 38.0 degrees, and the treatment was terminated in 45 minutes after resuming the procedure.After the treatment, the patient could not stand up by herself.Because of strong fatigue and high inflammatory response, she was hospitalized after er visit.

• 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: kazuhiko inoue ; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 530-8-288 ; JA 530-8288 ; 4613072
• MDR Report Key: 7410392
• MDR Text Key: 104799446
• Report Number: 3002808904-2018-00005
• 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: 03/16/2018

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
• 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: 03/16/2018
• Initial Date FDA Received: 04/09/2018
• 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
• Patient Age: 74 YR
• Patient Weight: 41