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

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypovolemic Shock (1917); Hypovolemia (2243)

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

Since the lixelle and the connecting tube are pvp free, a possibility of developing pvp allergy can be excluded.Those devices are steam sterilized and a possibility of ethylene oxide (eto) allergy can also be excluded.The incident occurred in the very first treatment with lixelle s-15.According to the treatment parameters provided by the treatment site, the patient was overhydrated by 3.3 kg (6.3%) to the estimated ideal weight (b)(6) before starting the treatment.Due to his overhydrated condition, a relatively higher dehydration rate at 700-1,000 ml/hr compared to that in standard hd procedures (500-700 ml/hr in general), with the blood flow rate of 230 ml/min, was applied.Since the lixelle is used connecting in series to a hemodialyzer, the extracorporeal volume (the blood circulating outside the body) increases by a priming volume of the lixelle s-15 from that of the hd system alone.It might be possible that a higher dehydration rate and the increased extracorporeal volume enhanced a hypovolemic status to cause the severe hypotension resulting in a shock symptom.This report is delayed because it was sent to the emdr test instead of production.

Event Description

The case was a male patient on his 60s of age with chronic hemodialysis (hd) accompanied with dialysis-related amyloidosis (dra).When an on-line hemodiafiltration (hdf) was introduced to the patient in order to improve worsened symptoms of dra, he experienced a significant hypotension at 30 min.After beginning the treatment.The blood test revealed that he was positive in allergy to polyvinylpyrrolidone (pvp).The hdf was switched to a hemodialysis (hd) by using a polysulfone hemodialyzer, aps (asahi kasei medical), but a significant hypotension reoccurred in 12th or 13th hd with the aps, and then, the hemodialyzer was changed to a cellulose triacetate hemodialyzer, fb-190ub (nipro), and the complication had not recurred since then.Since his dra exacerbated again, lixelle s-15, beta2-microglobuline adsorption column, was added on the hd with the fb-190ub.In his first hd with the lixelle, his blood pressure (bp) dropped from 148 mmhg to 72 mmhg at about one hour after starting the treatment and he fell into a state of shock.The treatment was stopped immediately and he recovered with a saline infusion.His bp returned to 130's mmhg at the termination of the treatment.

• 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, 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: 6203729
• MDR Text Key: 63620382
• Report Number: 9614654-2016-00007
• 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: 02/24/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2016
• 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
• Treatment: DIALYZER FB-190UB(NIPRO CO.,LTD.)
• Patient Outcome(s): Life Threatening
• Patient Weight: 56