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

Catalog Number S-35

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

Patient Problems Fever (1858); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Chills (2191)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

This patient had been tolerated well with lixelle until 26th treatments.The cause of fever, chills, tachycardia is unknown.After administration of antibiotics, these symptoms ceased and there is a possibility that some kind of infection might have occurred.The column size of lixelle was stepwise increased from s-15, s-25 and then to s-35, and this incident occurred when the largest s-35 was used.The possibility of the decrease in blood pressure accompanied by increase in extracorporeal circulation volume cannot be denied.

Event Description

The patient was a male patient on chronic hemodialysis (hd), and had received hd with lixelle, 3 times per week, since (b)(6) 2016.The column size of the lixelle used was increased from s-15 (150ml), s-25 (250ml) and then to s-35 (350ml).On (b)(6) 2016 (in the previous treatment with lixelle s-35, 2 days before the date of this incident) he alleged symptoms at around 20 min.Before the end of the treatment.He was tachycardic, had more chills with fever (around 101.5 f).He refused to go to er and got chest x ray done at that time.He felt better after getting antibiotics (vanco 1g & cefepime 2g since he was allergic to gentamycin.).Because infection was suspected, a blood culture was done (the results was negative as of (b)(6) 2016).On (b)(6) 2016, it was his 28th treatments with lixelle, where s-35 was used, he complained mild chills with fever of 101.2 f towards the end of the treatment.Vanco 1g & cefepime 2g iv were given after the treatment and his symptoms ceased.A blood culture was done again.He has had fluid overload since the previous treatment (700ml positive because he was given considerable amount of normal saline post hd due to hypotension).However, he had remained hypotensive.Sbp checked between 70 and 80mmhg (lying down).O2 sat 94% with oxygen 3l/min via nc.He decided to go to er.He was hospitalized on (b)(6) 2016 and has being hospitalized since then.

• 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 ; 31814120
• MDR Report Key: 6203743
• MDR Text Key: 63259751
• Report Number: 9614654-2016-00024
• Device Sequence Number: 1
• Product Code: PDI
• UDI-Device Identifier: 14993478020218
• UDI-Public: 14993478020218
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H130001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: S-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2016
• 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: 58 YR