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U.S. Department of Health and Human Services

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

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GAMBRO INDUSTRIES PRISMAFLEX SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number M100
Device Problems Fluid Leak (1250); Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/03/2020
Event Type  malfunction  
Event Description
Set up new continuous renal replacement therapy set air noted in return line upon starting. Tubing took down and re-primed new set. Once second new set started, fluid leaking from access line/y-site for acid citrate dextrose-solution a and stopped again. Lot number 19c0608 on both sets.
 
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Brand NamePRISMAFLEX SET
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO INDUSTRIES
one baxter parkway
deerfield IL 60015
MDR Report Key10312080
MDR Text Key199989972
Report Number10312080
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 07/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM100
Device Catalogue Number106697
Device Lot Number19C0608
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/13/2020
Event Location Hospital
Date Report to Manufacturer07/23/2020
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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