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 Low Blood Pressure/ Hypotension (1914); Hypovolemic Shock (1917)

Event Date 09/03/2018

Event Type  Injury  

Manufacturer Narrative

The increase in extracorporeal circulation volume due to the combination of lixelle column to compare with dialysis only may cause a decrease in blood pressure although saline administration as supplementation fluid did not improve the decreased bp so much.Since the treatment conditions of lixelle had not been changed until (b)(6) when the abrupt decrease in bp was reported for the first time, the cause is unknown.

Event Description

Event narrative: lixelle s-15 in combination with a dialyzer was used for the treatment of dialysis-related amyloidosis.Lixelle treatment with dialysis (lixelle) started from (b)(6) 2017, and had been conducted without problems.On (b)(6) 2018 lixelle for 4 hours was planned.The patient complained of constipation and loss of appetite before lixelle.Since blood pressure (bp) dropped to 80 mmhg and symptoms such as, cold sweats, nausea, headache, stomachache, etc were observed during the treatment, the lixelle was terminated in 3 hours.A total of 700 ml of saline was administered during the lixelle.On (b)(6), (b)(6), (b)(6), and (b)(6), hemodialysis treatments only were conducted.Bp during the hemodialysis was stable at around 150 mmhg.On (b)(6) lixelle was resumed and at the start bp was 159 mm hg.At 15 min after lixelle bp decreased to 116 mmhg, and 100ml of saline was administered.At 30 min bp decreased to 81 mmhg.At 40 min the patient complained of feeling bad, and 100 ml of saline was administered.The bp was 90 mmhg.At 45 min bp was 78 mmhg, and 200 ml of saline was administered.At 80 min bp was 105 mmhg.Even after administration of saline bp showed no recovery.Lixelle was terminated at 80 min.On (b)(6) hemodialysis treatment only was tried for 5 hours and was found to be no problem.Other complications: cholesterol crystal embolization on (b)(6) 2015 pta of right lower limb thrombosis on (b)(6) 2015 and (b)(6) 2015 amputation of lower limb on (b)(6) 2016 ldl apheresis for 10 times from (b)(6) 2015, and ldl apheresis for 10 times from (b)(6) 2017.Chocolate cyst.Spinal canal stenosis.Fever on the day of dialysis.

• Brand Name: LIXELLE
• 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: 8072411
• MDR Text Key: 127209926
• Report Number: 3002808904-2018-00018
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2018

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: 10/19/2018
• Initial Date FDA Received: 11/14/2018
• 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; Other
• Patient Age: 68 YR