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

Model Number S-15

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Chest Pain (1776); Low Oxygen Saturation (2477); Presyncope (4410)

Event Date 03/27/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 314074070
• Report Number: 3002808904-2023-00003
• Device Sequence Number: 1
• Product Code: PDI
• UDI-Device Identifier: 14993478020218
• UDI-Public: 14993478020218
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• 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: 03/31/2023
• Initial Date FDA Received: 04/27/2023
• 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: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian