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	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device has not been analyzed yet since the actual product was just arrived at (b)(4).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.We have received the complaint sample and analysis is being performed now.We are going to prepare a follow-up report as soon as we get the result of the analysis.
Event or Problem Description
On (b)(6) 2018, the patient was given the treatment with hemodialysis (hd) using rexeed-25s.A nurse placed needles in fistula without problems, and started the treatment.Arterial pressure alarmed multiple times approximately 5-7 minutes into the treatment and the nurse attempted to adjust the needle without success.The nurse started to recirculate to try to adjust the needles.Since arterial pressure alarmed on the dialysis machine, the nurse did not check if the blood was clotted when the machine was recirculated.As soon as machine was started to recirculate, blood clots were coming out of the arterial head of the dialyzer.After further investigation, it was discovered that patient's access was clotted and the patient was sent to interventional radiology to remove blood clots.Patient did not have any issues with this incident.
Additional Manufacturer Narrative
Out of 9 submitting reports to fda, mfr report #: 8010002-2018-00030, 8010002-2018-00050, 8010002-2018-00060, 8010002-2018-00070, 8010002-2018-00080, 8010002-2018-000100, 8010002-2018-00110, 8010002-2018-00130, and 8010002-2018-00165, 2 actual complaint samples were returned to be analyzed, mfr report #:8010002-2018-00050 and 8010002-2018-00165.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.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.The incidents of these header leakage occurred at the 4 facilities and 7 out of 9 incidents were reported from the same 2 facilities, 5 incidents from (b)(6) and 2 incidents from (b)(6) in u.S.

• 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; chiyoda-ku; tokyo, 100-0 006; JA 100-0006
• MDR Report Key: 7701652
• Report Number: 8010002-2018-00165
• Device Sequence Number: 805301
• 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,Followup
• Report Date (Section B): 06/22/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 09/21/2018
• 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