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U.S. Department of Health and Human Services

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

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GAMBRO RENAL PRODUCTS, INCORPORATED PRISMAFLEX SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number M100
Device Problems Device Displays Incorrect Message (2591); Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/10/2019
Event Type  malfunction  
Event Description
M100 circuit for continuous renal replacement therapy (crrt) was pulling air, needed to be re-primed twice and was still not working appropriately. Risk of air or reaching was real. Error message began to appear. Crrt coordinator was present with bedside nurse. Decision made to pull that circuit from you and re-prime with new circuit. New circuit used without incident or error. Patient successfully placed on crrt and is stable at this time. No other issues with new circuit.
 
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Brand NamePRISMAFLEX SET
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO RENAL PRODUCTS, INCORPORATED
14143 denver west pkwy
lakewood CO 80401
MDR Report Key9150702
MDR Text Key161038784
Report Number9150702
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 Risk Manager
Type of Report Initial
Report Date 09/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM100
Device Catalogue Number106697
Device Lot Number18K1401
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/20/2019
Event Location No Information
Date Report to Manufacturer10/03/2019
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?
Type of Device Usage

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