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	10/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Actual complaint sample was returned and was analyzed at oita works.The result of inflicting air pressure on the actual collected product, air leakage was detected between the arterial header and housing portion of defect welding parts.We decided that the incident of blood leakage was caused by this defect of welding.Also, we investigated the manufacturing and quality control records of complaint products based on all lot numbers.According to the investigations, no potential for malfunction was found, and we have not received any similar incident regarding this lot number.To reconfirm if the products meet product standard, air pressure test was conducted on the same products which were manufactured the same line as complaint products and the header leakage did not occur even though pressure of 100 kpa was applied.Therefore, we judged that pressure capacity of the products is guaranteed as well as products are within the range of product standard.In 2018, the incidents of these header leakage occurred at the 6 facilities and 11 out of 15 incidents were reported from the same 2 facilities, 5 incidents from (b)(6) in (b)(6) and 6 incidents from (b)(6) in u.S.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 hansen is an incident which might cause serious injury to the patient.
Event or Problem Description
Patient was in outpatient dialysis unit for regularly scheduled dialysis treatment 3 days a week.Patient was prescribed a treatment length of 4 hr 15 minutes.Dialysate flow rate was 800 ml/min and dialysate temperature 36 c.Patient's dry weight was (b)(6), he was set for a target loss of 3.4 kg.On (b)(6) 2018, 06:55, dialysis of rexeed-25s was initiated.On (b)(6) 2018, approximately 07:25, patient's alarm on machine started sounding with an arterial pressure alarm.Nurse went over to machine, and it appeared that blood and liquid was coming out of the arterial hansen dripping onto to floor (his approximate blood volume loss: roughly 100 cc).Pump was stopped, and patient was disconnected.Rinse back was not given.Machine was changed out.The patient's health condition was stable, and did not need any medical interventions.

• 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: 8050028
• Report Number: 8010002-2018-00190
• Device Sequence Number: 13873990
• Product Code: KDI
• UDI-Device Identifier: 04537693003927
• UDI-Public: (01)04537693003927(17)210212(10)UH2X2B
• 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): 10/13/2018

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: 02/12/2021
• Device Model Number: REXEED-25S
• Device Catalogue Number: N/A
• Device Lot Number: UH2X2B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2018
• Initial Report FDA Received Date: 11/08/2018
• 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
• Patient Weight: 123