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

Model Number APS-18SA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Shock (2072)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

The product of this event was not returned to the manufacturer and could not be analyzed; however we investigated manufacturing and quality control records based on the lot number.According to the investigation, no potential for malfunction was found.(b)(4) pieces of lot ak797g were manufactured, and no similar event has been reported with this lot number globally so far.We also reported this incident separately on mfr report number 3007340888-2020-00050.The physician determined, this event as serious.The physician also commented that this event seems to be an allergic response to the membrane material used for product, because the patient is allergic to cats, and the eosinophil value and ige value were both high, as well as the adverse events occured from the sixth time of product use.We considered, this event as "serious" because the patient's systolic blood pressure was decreased to 55 mmhg from 133 mmhg after 20 minutes of the treatment and went into shock.Also, the patient was discontinued the treatment since he did not improve after administering sodium chloride and oxygen, and the physician judged as "serious".The event occurred 20 minutes after the initiation of the treatment.Therefore, a causal relationship could no be denied.In adverse reactions in ifu of rexeed-s, it is described as "patients with a history of hypersensitivity reactions or those prone to hypersensitivity should be carefully monitored by the physician.It is recommended that, based on the physicians directions, treatment should be discontinued if signs or symptoms of hypersensitivity are exhibited." and "side effects such as hypertension, hypotension, headache, and nausea that may be associated with hypovolemia or hypervolemia can usually be avoided by careful management of the patient's fluid, electrolyte balance, blood flow rate, and transmembrane pressure (tmp)." we will continue to monitor the occurrence of similar events carefully.

Event Description

This incident occurred in (b)(6).Aps-sa series is identical model to rexeed-s series marketed in us.On november 16, the patient's systolic blood pressure, which was 133 mmhg at the beginning of treatment, decreased to 55 mmhg 20 minutes after the start of treatment.He complained of difficulty breathing and went into shock.Fluid removal was immediately stopped, and sodium chloride 100 ml and oxygen were administered.Three minutes later, sodium chloride 100 ml was added and the systolic blood pressure increased to 78 mmhg.Two minutes later, the treatment was stopped and blood was returned since the patient still complained of difficulty breathing even though the oxygen administration was increased.Twelve minutes after completing the blood return, the systolic blood pressure recovered to 100 mmhg.

• Brand Name: ASAHI REXEED-S SERIES DIALYZERS
• Type of Device: DIALYZER, HIGH PERMEABILITY
• Manufacturer (Section D): ASAHI KASEI MEDICAL CO., LTD.; 1-1-2 yurakucho; chiyoda-ku; tokyo, 100-0 006; JA 100-0006
• Manufacturer (Section G): ASAHI KASEI MEDICAL MT CORP. OKATOMI PLANT; 5-4960; nakagawara-machi; nobeoka-shi, 882-0 031; JA 882-0031
• Manufacturer Contact: naomi kagami ; 1-1-2 yurakucho; chiyoda-ku; tokyo, 100-0-006 ; JA 100-0006
• MDR Report Key: 11051975
• MDR Text Key: 223135099
• Report Number: 3007340888-2020-00040
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: APS-18SA
• Device Catalogue Number: N/A
• Device Lot Number: AK797G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NIKKISO DBB-27
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 86