MAUDE Adverse Event Report: ASAHI KASEI MEDICAL CO., LTD. ASAHI REXEED-S SERIRS DIALYZERS DIALYZER, HIGH PERMEABILITY, PRODUCT CODE: KDI, PRODUCT CODE: KDI

Model Number REXEED-25A

Device Problems Fluid Leak (1250); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

We decided to report this incident since we consider blood leak from the arterial header is an incident which might cause serious injury to the patient. We are going to prepare a final report to fda as soon as we received the actual complaint product and complete its analysis. In addition, the following cautions are given to 4. Warnings of ifu of rexeed-s. Warnings: in the event of a problem during treatment, such as blood leakage or coagulation, immediately discontinue the treatment under the direction of a physician and replace rexeed-s with a new primed dialyzer.

Event Description

This incident occurred in korea and is reported to fda according to the requirement. Rexeed-a series is identical model to rexeed-s series marketed in us. For the dialysis patients, set the dialysis time to 4. 5 hours, hemodiafiltration with a blood flow rate of 350 ml / min, dialysate flow rate of 600 ml / min, filtration volume of 24 l (post), and uf water removal setting of 3. 6 l hemodiafiltration (hdf) treatment was started. During the dialysis treatment a v-pressure alarm occurred and about 2 hours later, 20 minutes before the end of treatment, a blood leak of about 2 to 3 ml was found from the dialyzer header. Blood pressure during treatment ranged from 107 to 130 mmhg. After the blood leak was found, dialysis treatment was stopped. The patient's condition is stable and no treatment has been performed. It was confirmed that the patient had no infectious disease.

• Brand Name: ASAHI REXEED-S SERIRS DIALYZERS
• Type of Device: DIALYZER, HIGH PERMEABILITY, PRODUCT CODE: KDI, PRODUCT CODE: KDI
• Manufacturer (Section D): ASAHI KASEI MEDICAL CO., LTD.; 1-1-2 yurakucho; chiyoda-ku; tokyo, 100-0 006; JA 100-0006
• Manufacturer (Section G): ASAHI KASEI MEDICAL MT CORP. OITA WORKS; 2111-2; oaza sato; oita-shi, 870-0 396; JA 870-0396
• Manufacturer Contact: naomi kagami ; 1-1-2 yurakucho; chiyoda-ku; tokyo, 100-0-006 ; JA 100-0006
• MDR Report Key: 11811714
• MDR Text Key: 252951336
• Report Number: 8010002-2021-00030
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K153344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: REXEED-25A
• Device Catalogue Number: N/A
• Device Lot Number: VK393B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/12/2021 Patient Sequence Number: 1