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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASAHI KASEI MEDICAL CO., LTD. ASAHI REXEED-S SERIRS DIALYZERS DIALYZER, HIGH PERMEABILITY, PRODUCT CODE: KDI, PRODUCT CODE: KDI

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ASAHI KASEI MEDICAL CO., LTD. ASAHI REXEED-S SERIRS DIALYZERS DIALYZER, HIGH PERMEABILITY, PRODUCT CODE: KDI, PRODUCT CODE: KDI Back to Search Results
Model Number REXEED-25A
Device Problems Fluid Leak (1250); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2021
Event Type  malfunction  
Manufacturer Narrative
We decided to report this incident since we consider blood leak from the arterial header is an incident which might cause serious injury to the patient. We are going to prepare a final report to fda as soon as we received the actual complaint product and complete its analysis. In addition, the following cautions are given to 4. Warnings of ifu of rexeed-s. Warnings: in the event of a problem during treatment, such as blood leakage or coagulation, immediately discontinue the treatment under the direction of a physician and replace rexeed-s with a new primed dialyzer.
 
Event Description
This incident occurred in korea and is reported to fda according to the requirement. Rexeed-a series is identical model to rexeed-s series marketed in us. For the dialysis patients, set the dialysis time to 4. 5 hours, hemodiafiltration with a blood flow rate of 350 ml / min, dialysate flow rate of 600 ml / min, filtration volume of 24 l (post), and uf water removal setting of 3. 6 l hemodiafiltration (hdf) treatment was started. During the dialysis treatment a v-pressure alarm occurred and about 2 hours later, 20 minutes before the end of treatment, a blood leak of about 2 to 3 ml was found from the dialyzer header. Blood pressure during treatment ranged from 107 to 130 mmhg. After the blood leak was found, dialysis treatment was stopped. The patient's condition is stable and no treatment has been performed. It was confirmed that the patient had no infectious disease.
 
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Brand NameASAHI REXEED-S SERIRS DIALYZERS
Type of DeviceDIALYZER, HIGH PERMEABILITY, PRODUCT CODE: KDI, PRODUCT CODE: KDI
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, 870-0 396
JA 870-0396
Manufacturer Contact
naomi kagami
1-1-2 yurakucho
chiyoda-ku
tokyo, 100-0-006
JA   100-0006
MDR Report Key11811714
MDR Text Key252951336
Report Number8010002-2021-00030
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K153344
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREXEED-25A
Device Catalogue NumberN/A
Device Lot NumberVK393B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2020
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: 05/12/2021 Patient Sequence Number: 1
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