MAUDE Adverse Event Report: KANEKA CORPORATION LIXELLE BETA2-MICROGLOBULIN APHERESIS COLUMN; BETA 2-MICROGLOBULIN APHERESIS COLUMN

Model Number S-25

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Syncope/Fainting (4411)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

Our view.The facility has not reported any defects and malfunction in the product, and we determine that it is due to the patient's condition and usage.However, since health hazards to patients have occurred, and the causal relationship between health hazards and the product cannot be completely ruled out, we will submit mdr (30 days).

Event Description

The patient has been treated with lixelle from january 2020 to december 2020 (1 year) and is prone to decrease in blood pressure even with normal dialysis treatment.In (b)(6) 2021, she took a month off from lixelle treatment.Lixelle treatment was resumed on (b)(6) 2021, but a problem occurred on (b)(6) 2021.Following gastric discomfort, blood pressure decreased about 2 hours after the start of treatment.Blackouts, but recovered by treatment of medical staff.The time series information is shown below.Dialysis start time 15:45.17:30 blood pressure 99 17:40 chest discomfort occurred and lower limbs were elevated.17:50 the medical staff noticed that the blood pressure was low, and when the patient was confirmed, it was oculogyric and the consciousness level was jcs2-20.When the removal of body fluid was stopped and lower limb elevation and fluid replacement 200 ml were performed, the blood pressure increased to 160 range.Spo2 96%, consciousness level recovered to responsive state.Resumed removal of body fluid 18:10 blood pressure 121 19:05 blood pressure 76/53 symptom improvement 19:20 blood pressure 96/71 19:45 end of dialysis.

• Brand Name: LIXELLE BETA2-MICROGLOBULIN APHERESIS COLUMN
• Type of Device: BETA 2-MICROGLOBULIN APHERESIS COLUMN
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; kita-ku, nakanoshima; osaka, 23082 88; JA 2308288
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1; torikai-nishi; settsu-shi, osaka 56600 72; JA 5660072
• Manufacturer Contact: joji sengoku ; 1-12-32; akasaka; minato-ku, tokyo 107-6-028 ; JA 107-6028
• MDR Report Key: 11418275
• MDR Text Key: 245400887
• Report Number: 3002808904-2021-00003
• Device Sequence Number: 1
• Product Code: PDI
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• 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
• Date Manufacturer Received: 02/08/2021
• 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): Other
• Patient Age: 59 YR