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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 REXEED-25A
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 03/28/2018
Event Type  Injury  
Manufacturer Narrative
This incident of "hypersensitivity reaction" occurred in (b)(6) and is reported to fda according to the requirement. Rexeed-25a is identical model to rexeed-25s marketed in us. We could not receive the actual product so far. However, we investigated manufacturing and quality control records based on the lot number. We have not received any similar event under this lot number. We decided to report this incident since we consider hypersensitivity reaction which include dyspnea at rest to be the serious adverse event. 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
On (b)(6) 2018 as soon as the male patient has started the treatment with rexeed-25a, which is a similar product of rexeed-25s, he was not feeling well, and experienced hypersensitivity reaction (hot tongue ; heavy salty taste in mouth, abdominal and thoracic oppression, dyspnea, laryngeal edema, generalized pruritus all over his body). Treatment to his hypersensitivity reaction: blood recovery, disconnection of the treatment, oxygen therapy, and solumedrol (corticosteroids) : 10 mg. His electrocardiogram and blood test was performed. After 30 min, his symptoms disappeared, and the patient was given the treatment with another dialysis machine.
 
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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 Key8072831
MDR Text Key127203511
Report Number8010002-2018-00210
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K153344
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 10/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2020
Device Model NumberREXEED-25A
Device Catalogue NumberN/A
Device Lot NumberQG797B
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 Received10/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2017
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: 11/15/2018 Patient Sequence Number: 1
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