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 Problem Low Blood Pressure/ Hypotension (1914)

Event Date 09/14/2022

Event Type  Injury  

Event Description

About 1 hour and 30 minutes after the start of treatment, the systolic blood pressure dropped to the 50 mmhg level after the development of yawning.We performed leg elevation, electrolyte replenishment, and discontinuation of dialysis (ultrafiltration), but the blood pressure did not improve, so extracorporeal circulation treatment was discontinued.

Manufacturer Narrative

Our view: there were no reports of product defects, etc.From the facility, and we determined that the cause of the adverse events was the patient's condition and method of use.When the blood pressure dropped, no symptoms such as nausea or a decline in the level of consciousness were observed in the patient, but it was surmised that systolic blood pressure of the 50 mmhg level "may cause serious damage to peripheral tissues".The case was judged to be a "serious" case.In addition, since a causal relationship between the adverse event and the product cannot be completely denied, it was determined that the mdr 30-day report applies.

• 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, 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: 15602427
• MDR Text Key: 301728378
• Report Number: 3002808904-2022-00013
• Device Sequence Number: 1
• Product Code: PDI
• 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: 10/14/2022

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: 09/16/2022
• Initial Date FDA Received: 10/14/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian