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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 HF1400
Device Problems Complete Blockage (1094); Defective Device (2588); Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 08/24/2021
Event Type  malfunction  
Event Description
Nursing staff were attempting to change out the filter cartridge on the "baxter prismax" continuous renal replacement therapy (crrt) machine, and 4 times in a row, received the same error message on the screen after the machine attempted to prime the lines with iv fluid. The machine takes 10 minutes to prime the iv lines, and on all 4 occasions, the timer stopped at 9:08, stating that there was a blockage in the line, which there was not. Each time this stoppage happened, an entire new filter must be brought out, and all of the iv bags must be replaced, which takes approximately 30 minutes. With this happening 4 times in a row, it caused an approximate 2-hour delay in patient care. The 5th filter that was used worked properly, and the staff was able to continue with the crrt for the patient. All 4 of the failed filters were from the same lot number.
 
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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 Key12438289
MDR Text Key270306772
Report Number12438289
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 08/30/2021,08/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHF1400
Device Catalogue Number107142
Device Lot Number21B2204
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/30/2021
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer09/08/2021
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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