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

Model Number APS-21SA

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/17/2018

Event Type  Injury  

Manufacturer Narrative

This incident of "hypersensitivity reaction" occurred in (b)(6) and is reported to fda according to the requirement.Aps-21sa is identical model to rexeed-21s 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.As the gastroenterologist advised him to be hospitalized, we considered that he judged this case as serious injury.He considered that this case is hypersensitivity (allergic reaction in the narrow sense) induced by the combination with medicine and dialysis.The relationship between this case and the adverse event could not be denied.We decided to report this incident since we consider hypersensitivity reaction was the serious adverse event, because this patient experience fever (38.2) and generalized rash, and was advised to be hospitalized.The relationship between this case and this product is suspicious, because he did not experience the symptom when he was given the 2nd treatment with the 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

In the previous hospital, this male patient was given the treatment of dialysis aps-15sa, which is an identical dialyzer of rexeed-15s sold in us, the patient experienced fever and rash, soon after the start of the dialysis.Some anticoagulants like futhan (nafamostat mesilate), heparin sodium injection etc.Were used.The cause of the symptom could not be specified, but the diagnosis of dermatologist was "allergic reaction caused by the medicines related to dialysis".(b)(6) 2018 (initial treatment): this patient was given the first treatment with aps-21sa, which is an identical dialyzer of rexeed-21s sold in us, in this hospital.After two hours from initiation, he experienced chill, fever (38.2), mild rash pruritic on his arm.After three hours from initiation, the dialysis treatment was completed as scheduled.Patient's blood pressure was stable as followed: blood pressure before treatment: 115/69mmhg, blood pressure after treatment: 130/70mmhg.Eosinophil granulocyte was 20-30%.After this patient returned home, he visited his attending gastroenterologist of duodenal ulcer and dermatologist, and dermatologist diagnosed his symptom as generalized papuloerythematous drug eruption.Gastroenterologist advised him to be hospitalized again, but he was not hospitalized because of his will.After he returned home, in the evening his rash on the arm became generalized, and his fever did not break.He was treated with the claritin tablets(loratadine), antebate ointment(betamethasone butyrate propionate), hirudoid soft ointment(heparinoid), and locoid ointment(hydrocortisone butyrate).(b)(6) 2018 (2nd treatment): the patient completed the treatment of the other company's dialyzers for four hours without any problem.After this day, the concomitant medicines were stopped because of his will, pruritic condition on his skin disappeared.From (b)(6) 2018 (3rd-5th treatment): this patient was given the treatment of the other company's dialyzers twice a week.No further dialysis treatment has not been given since his fifth treatment was completed, because the residual blood volume was large.(b)(6) 2018: the treatment with stomach medicine (nexium) was started again in accordance with the advice of the gastroenterologist, then he began to experience pruritus in the ordinary times.(b)(6) 2018 (6th treatment): he was given the treatment of other company's dialyzer, which is different from those used from the 2nd treatment to 5th treatment, and the treatment was completed, he experienced fever (37.7) and rash on his arm.

• 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: 8178153
• MDR Text Key: 130794600
• Report Number: 8010002-2018-00220
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: APS-21SA
• 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: 11/21/2018
• 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
• Treatment: BAYASPIRIN(ASPIRIN); CARVEDILOL(CARVEDILOL); CILNIDIPINE(CILNIDIPINE); FEBURIC TABLETS(FEBUXOSTAT); NEXIUM CAPSULES(ESOMEPRAZOLE MAGNESIUM HYDRATE); NIFEDIPINE(NIFEDIPINE); OLMESARTAN TABLETS(OLMESARTAN MEDOXOMIL); PRAVASTATIN(PRAVASTATIN SODIUM); ZOLPIDEM(ZOLPIDEM TARTRATE)
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 63