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 Codes	Dyspnea (1816); No Code Available (3191)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device has not been analyzed yet since the actual product has not been arrived at oita works.However, we investigated manufacturing and quality control records based on the lot number.According to the investigation, no potential for malfunction was found.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 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.
Event or Problem Description
On (b)(6), 2018, the patient was given the treatment with hemodialysis (hd) using rexeed-25s.At 12:15 pm, the treatment was started.The patient was very restless and had shortness of breath from the beginning of his treatment.Despite his restlessness, his catheter was running without any problem and machine was not frequently alarming.At 13:56 pm, the patient requested to get out of his bed and transfer to the dialysis chair so the nurse disconnected the patient from the dialysis system and put the system into recirculation.At 14:05 pm, the machine alarmed due to high venous pressure, the nurse pressed the reset key to restart the machine.Upon the blood pump starting, the nurse heard a crack and blood started pouring out of the top of the dialyzer.The treatment was stopped and the patient continued treatment with new primed dialyzer without incident.Patient condition was stable.

• 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: 7831291
• Report Number: 8010002-2018-00180
• Device Sequence Number: 2446893
• Product Code: KDI
• UDI-Device Identifier: 04537693003927
• UDI-Public: (01)04537693003927(17)201015(10)UGXEXG
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2018

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: 10/15/2020
• Device Model Number: REXEED-25S
• Device Catalogue Number: N/A
• Device Lot Number: UGXEXG
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/29/2018
• 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