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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-25S
Device Problem Leak/Splash (1354)
Patient Problem Malaise (2359)
Event Date 05/12/2018
Event Type  malfunction  
Manufacturer Narrative
The used device could not be analyzed since it was discarded by the user facility. Manufacturing and quality control records were also unable to investigate since the lot number was unavailable. The blood leakage is described in warnings of the instructions for use as "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". 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.
 
Event Description
On (b)(6) 2018, the patient was given the treatment with hemodialysis (hd) using rexeed-25s. A nurse turned off an elevated arterial pressure alarm 2 to 3 times for the first 30 minutes of the treatment and there was no problems observed. A high venous pressure alarmed about 30 minutes after the treatment started and when the nurse went over to turn off the alarm, a blood leak at the arterial header of the dialyzer was found. The patient's blood was unable to return. None of the medical intervention, hospitalization, and blood transfusion was required as well as no changes in medications, erythropoietin, was prescribed as patient's condition was stable. Patient reported malaise for 24 hours after the incident.
 
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Brand NameASAHI REXEED-S SERIES DIALYZERS
Type of DeviceDIALYZER, HIGH PERMEABILITY
Manufacturer (Section D)
ASAHI KASEI MEDICAL CO., LTD.
1-105, kanda jinbocho
chiyoda-ku
tokyo, 101-8 101
JA 101-8101
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
1-105, kanda jinbocho
chiyoda-ku
tokyo, 101-8-101
JA   101-8101
32963735
MDR Report Key7644550
MDR Text Key112871457
Report Number8010002-2018-00140
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153344
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREXEED-25S
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2018
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: 06/28/2018 Patient Sequence Number: 1
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