MAUDE Adverse Event Report: ASAHI KASEI MEDICAL CO., LTD. ASAHI REXEED-S SERIES DIALYZERS; DIALYZER, HIGH PERMEABILITY

Model Number	REXEED-25S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual product was not returned to our company, but lot number was known, so we investigated the manufacturing and quality control records of lot#vh979x.As a result, no abnormality was found in records.(b)(4) pieces of lot#vh979x were manufactured, and no similar event using this lot#vh979x was reported globally.We could not investigate the root cause of this event because actual product could not be returned.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.The blood leakage is described in warnings of the instructions for use as "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".We will continue monitoring occurrence of these kinds of incidents.
Event or Problem Description
(b)(6) 2019, this event occurred during the treatment with rexeed-25s.This clinic primed with 1000 ml of normal saline and recirculated the dialyzer for about 5 minutes.After 90 minutes from the treatment start, the venous pressure alarmed, and then the blood leak from the arterial header occurred.After this event, this patient's condition was stable, and the patient did not require medical attention, there was neither need for blood transfusion nor for adjusting erythropoietin(epo) dosage.The patient left the dialysis room in stable condition.

• Brand Name: ASAHI REXEED-S SERIES DIALYZERS
• Common Device Name: DIALYZER, HIGH PERMEABILITY
• Manufacturer (Section D): ASAHI KASEI MEDICAL CO., LTD.; 1-1-2 yurakucho; chiyoda-ku; tokyo 100-0 006; JA 100-0006
• MDR Report Key: 8525800
• Report Number: 8010002-2019-00060
• Device Sequence Number: 1870550
• Product Code: KDI
• UDI-Device Identifier: 04537693003927
• UDI-Public: (01)04537693003927(17)210909(10)VH979X
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2021
• Device Model Number: REXEED-25S
• Device Catalogue Number: N/A
• Device Lot Number: VH979X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other