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U.S. Department of Health and Human Services

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

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ASAHI KASEI MEDICAL CO., LTD. ASAHI REXEED-S SERIES DIALYZERS DIALYZER, HIGH PERMEABILITY Back to Search Results
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.
 
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Brand NameASAHI REXEED-S SERIES DIALYZERS
Type of DeviceDIALYZER, 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 Key8178153
MDR Text Key130794600
Report Number8010002-2018-00220
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K153344
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
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 Received12/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberAPS-21SA
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2018
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 Treatment Data
Date Received: 12/19/2018 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)
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