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

Model Number	S-15
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Chest Pain (1776); Low Oxygen Saturation (2477); Presyncope (4410)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our view: the item had already been disposed of, so it was not possible to confirm its condition.The lot number of the product was not reported and was not included in the disclosed information, so the manufacturing records, etc.Could not be confirmed.As there were no similar reports in the recent past, it was determined that there was no possibility that the cause of the event was a defect in the product.
Event or Problem Description
A patient (63 years old, male) who received the first treatment with this product on (b)(6) 2023 became in the state of "chest pain, unconsciousness, and decreased spo2 (93%)" about 1 hour after the start.Details of action taken: treatment was urgently stopped (finished), and steroid administration was implemented.Outcome: two days later, on (b)(6)2023, the patient's symptoms resolved.Further treatment with lixelle for this patient has been discontinued.In addition, we tried to obtain additional information multiple times, but we did not receive a response from the facility, so the details of the problem other than the above are unknown.

• Brand Name: LIXELLE BETA2-MICROGLOBULIN APHERESIS COLUMN
• Common Device Name: BETA 2-MICROGLOBULIN APHERESIS COLUMN
• Manufacturer (Section D): KANEKA CORPORETION; nakanoshima; kita-ku 2-3-18; osaka-shi, osaka 530-8 5288; JA 530-85288
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1; torikai-nishi; settu-shi, osaka 566-0 072; JA 566-0072
• Manufacturer Contact: joji sengoku ; 1-12-32; akasaka; minato-ku, tokyo 107-6-028 ; JA 107-6028
• MDR Report Key: 16821796
• Report Number: 3002808904-2023-00003
• Device Sequence Number: 17890079
• Product Code: PDI
• UDI-Device Identifier: 14993478020218
• UDI-Public: 14993478020218
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian