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U.S. Department of Health and Human Services

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

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GAMBRO AB PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 7.2
Device Problem Gas Leak (2946)
Patient Problem Blood Loss (2597)
Event Date 06/06/2020
Event Type  malfunction  
Event Description
The baxter (formally gambro) prismaflex crrt system (product code/ref#: 955542, serial #: (b)(4)) was set up and initiated per manufacturer instructions. Upon initiation the deaeration chamber and hemofilter filled with air. Blood could not be returned to the patient due to the risk of air embolism. 150ml of blood were loss due to the failure of the device. On (b)(6) of 2020, a similar baxter prismaflex crrt system, that had been red tagged for the same issue, was sequestered by the clinical/biomed team for repairs. The defective product was placed in a dedicated location for pick up. A "do not use" red tag was placed on the device.
 
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Brand NamePRISMAFLEX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO AB
one baxter parkway
deerfield IL 60015
MDR Report Key10302087
MDR Text Key199696809
Report Number10302087
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 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7.2
Device Catalogue Number955542
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/10/2020
Event Location Hospital
Date Report to Manufacturer07/21/2020
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/21/2020 Patient Sequence Number: 1
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