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U.S. Department of Health and Human Services

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

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GAMBRO RENAL PRODUCTS, INC. PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM SET Back to Search Results
Model Number M100
Device Problems Kinked (1339); Failure to Prime (1492)
Patient Problem No Information (3190)
Event Date 03/14/2017
Event Type  malfunction  
Event Description
During the priming of the continuous renal replacement therapy (crrt), the set failed priming. We believe that tubing has a defective kink by de-aeration chamber. A new set was obtained for priming.
 
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Brand NamePRISMAFLEX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM SET
Manufacturer (Section D)
GAMBRO RENAL PRODUCTS, INC.
9540 maroon cir fl 4
englewood CO 80112
MDR Report Key6456206
MDR Text Key71601020
Report Number6456206
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2018
Device Model NumberM100
Device Lot Number16B0306
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/20/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer03/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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