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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS, INC. REVACLEAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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GAMBRO RENAL PRODUCTS, INC. REVACLEAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 300
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 09/20/2021
Event Type  malfunction  
Event Description
The dialyzer has many fibers. During dialysis, as the rinse was occurring, a foreign particle was noted on the outside of the fibers.
 
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Brand NameREVACLEAR
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO RENAL PRODUCTS, INC.
14143 denver w pkwy
lakewood CO 80401
MDR Report Key12614515
MDR Text Key275916306
Report Number12614515
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number300
Device Catalogue Number114745L
Device Lot NumberC621304206
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/07/2021
Event Location Hospital
Date Report to Manufacturer10/12/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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