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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALUKART; APPARATUS, HEMOPERFUSION, SORBENT
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ALUKART; APPARATUS, HEMOPERFUSION, SORBENT Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Difficult to use on outpatient dialysis center.(b)(6).
 
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Brand Name
ALUKART
Type of Device
APPARATUS, HEMOPERFUSION, SORBENT
MDR Report Key9391844
MDR Text Key168596077
Report NumberMW5091370
Device Sequence Number1
Product Code FLD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/27/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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