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

Model Number	REXEED-21S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Dialyzer cracked 30 minutes after starting the treatment with blood flow rate at 450 ml/min, and dialysate flow rate at 800 ml/min.External blood leakage was found from the arterial, and venous headers by visual observation.Approximate blood volume loss was 50 ml.The patient was stable and did not need any medical intervention.Dialyzers with same lot number were used with no problem.

• 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: 10633148
• Report Number: 3007340888-2020-00030
• Device Sequence Number: 16824246
• Product Code: KDI
• UDI-Device Identifier: 04537693003910
• UDI-Public: (01)04537693003910(17)221011(10)AJX3XA
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 10/11/2022
• Device Model Number: REXEED-21S
• Device Catalogue Number: N/A
• Device Lot Number: AJX3XA
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BAXTER PHOENIX
• Outcome Attributed to Adverse Event: Other