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 Consequences Or Impact To Patient (2199)
Date of Event	12/28/2019
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#vhxxxa.As a result, no abnormality was found in records.No similar event using this lot#vhxxxa was reported globally.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
On (b)(6) 2019, this patient started the treatment with dialyzer, rexeed-25s.After 30 minutes from the beginning of the treatment, one side of the arterial header of the dialyzer housing lifted up, and the blood started coming out of the dialyzer.Therefore, the patient's treatment needed to be stopped urgently.All blood in the circuit was unable to be returned to the patient.The volume of the patient's blood loss was about 230 ml.

• 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: 9619907
• Report Number: 8010002-2020-00010
• Device Sequence Number: 18958435
• Product Code: KDI
• UDI-Device Identifier: 04537693003927
• UDI-Public: (01)04537693003927(17)211011(10)VHXXXA
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2020

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: 10/11/2021
• Device Model Number: REXEED-25S
• Device Catalogue Number: N/A
• Device Lot Number: VHXXXA
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/23/2020
• 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