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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-11SA
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Edema (1820)
Event Type  Death  
Manufacturer Narrative
We could not receive the actual product. Therefore, we could not investigate manufacturing and quality control records based on the lot number. Our opinion: according to the literature, one of the causes of cerebral edema is that though the serum osmotic pressure after dialysis decreases, the osmotic pressure in nerve cells becomes high due to accumulated methanol and its metabolites in nerve cells and then water flow into nerve cells. Two hours after the end of dialysis, ct showed cerebral edema, and hypercapnia was seen in the hospital, but hypercapnia and hypoxemia that caused cerebral edema during the subsequent course no symptoms have been seen. The causal relationship was evaluated as "cannot be denied" because the serum osmotic pressure may decrease after dialysis and water may flows into nerve cells. We considered that this event was serious adverse event because the outcome was death. The causal relationship between the event and aps-11sa was not denied, because the patient experienced the cerebral edema after her treatment. The caution as to this event is not written in the ifu of rexeed-s, but this case is the first adverse event whose causal relationship was not denied for us to receive, we will continue to monitor the occurrence of these kinds of events.
 
Event Description
This incident occurred in (b)(6) which collected from the literature and is reported to fda according to the requirement. Aps series is identical model to rexeed-s series marketed in us. She was developed cerebral edema. Medical history: insomnia, locomotive syndrome. A (b)(6) year old woman was treated as in an emergency room chiefly with a consciousness disorder. It was due to methanol intoxication that passed from 24 hours to 36 hours after the passage of time. The estimated methanol blood concentration was 331. 5 mg / dl. Considering the fact that metabolism from methanol to formic acid has already progressed since it had already metabolic acidosis with ph 6. 713, intermittent blood purification was attempted to remove blood methanol and formic acid. After completion of hemodialysis, the ph was improved up to 7. 623, but pupil dilatation occurred after 2 hours, and brain edema with remarkable psuedosah was found when head ct was reexamined. Administration of d-mannitol for cerebral edema did not work, and he died on the fourth hospital day. Causes of cerebral edema may be due to re-expansion of nerve cells due to the accumulation of methanol or its metabolite in nerve cells.
 
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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
ohme, tokyo 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 Key9942269
MDR Text Key187007654
Report Number8010002-2020-00060
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,literature
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberAPS-11SA
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 Received03/30/2020
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: 04/09/2020 Patient Sequence Number: 1
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