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

Model Number APS-25SA

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

This incident of "hypersensitivity reaction" occurred in (b)(6) and is reported to fda according to the requirement.Aps-25sa is identical model to rexeed-25s marketed in us.We could not receive the actual product.So, we could not investigate manufacturing and quality control records based on the lot number.Her doctor judged this case as serious injury (life-threatening).Her physician suspected this case to be anaphylactic reaction induced by the aps-25sa or by nafamostat mesilate, so the physician considered that the relationship between this case and aps-25sa to be suspicious.We decided to report this incident since we consider hypersensitivity reaction was the serious adverse event, because this patient's blood pressure decreased to 60mmhg and she was treated with vasopressor.The relationship between this case and this product is suspicious, because her symptom recovered after the aps-25sa was changed to other company's dialyzer.The hypersensitivity reaction is described in 4.Adverse reactions of the instructions for use 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 be discontinued if signs or symptoms of hypersensitivity are exhibited.These include acute shortness of breath with wheezing; respiratory arrest; itching; hives; generalized or localized redness of the skin; edema of the face, hands, or feet; hypertension above the baseline; elevated pulse rate; arrhythmia; ocular hyperemia; hypoesthesia; fever; leukopenia; and thrombocytopenia.".

Event Description

"treatment situation at previous hospitals" on (b)(6) 2019, this patient was under the condition of chronic renal disease in (b)(6).In two hospitals ago, this female patient was given the treatment of other company's dialyzer, and was taken to the previous hospital, and was given the treatment with aps-25sa which is an identical dialyzer of rexeed-25s sold in us, and with nafamostat mesilate.On (b)(6) 2019, she experienced fever during the treatment with aps-25sa under the same condition.On (b)(6) 2019, she was given the treatment with aps-25sa under the same condition, and developed blood pressure decreased, anal incontinence, and chest pain after two hours from the beginning of the treatment."the treatment situation at this hospital" on (b)(6) 2019, after this patient was transferred from the previous hospital, this patient was given the treatment with aps-25sa which is an identical dialyzer of rexeed-25s sold in us, and with nafamostat mesilate.Her blood pressure decreased to 65/44mmhg from 150/80mmhg after 5 minutes from the start of the treatment.On (b)(6) 2019, this patient was given the treatment with aps-25sa and with dalteparin sodium.After 5 minutes from the start of the treatment, her blood pressure decreased to 60/44mmhg from 150/80mmhg, and she experienced cough, so her blood was returned and she was treated with adrenaline 0.3mg intramuscularly twice.This patient's eosinophil count was high originally, her eosinophil count increased after the treatment with aps-25sa.She is now given the dialysis treatment under the same condition except the dialyzer and anticoagulants, along with steroid drugs without any problem.

• 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.; oita works; 2111-2 oaza sato; oita-shi, oita 870-0 396; JA 870-0396
• Manufacturer Contact: akitake yamashita ; 1-1-2 yurakucho, chiyoda-ku; tokyo 100-0-006 ; JA 100-0006
• MDR Report Key: 8415656
• MDR Text Key: 138645917
• Report Number: 8010002-2019-00020
• 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: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: APS-25SA
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR
• Patient Weight: 91