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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 PRISMAFLEX
Device Problems Melted (1385); Overheating of Device (1437); Smoking (1585); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/18/2018
Event Type  malfunction  
Event Description
There was an incident this morning with a crrt circuit heater that malfunctioned and burned through/melted a patient's return line. Fortunately, the patient appears to be unharmed but while the incident is being investigated by baxter, there are a few precautions to be taken. Nephrology has made it clear that they still want patients to have their circuit heaters on unless the patient is febrile. Please examine all circuit heater sleeves prior to placement on the return line - be looking for any breaks or bubbling in the material. Continue to intermittently examine the sleeve and the return line throughout therapy - this will require a removal of the sleeve with each shift to inspect line integrity as well. If you notice any changes in the sleeve or that it feels hotter than usual, peel away the sleeve to inspect the line. The issue has been taken to the top level of baxter (as well as our own risk management), so hopefully there will be more information to come. It may be something as simple as changing the cleaning solutions we use for the product. Additional information: in report of patient on crrt machine alarming and reached a hard limit and needed to be discontinued. Assisted night shift rn with take down and circuit warmer hose was hot to the touch with blister on surface opened warmer and crrt tubing melted and smoke /steam present. Notified charge rn immediately.
 
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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 Key8277376
MDR Text Key134117070
Report Number8277376
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 12/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRISMAFLEX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/28/2018
Event Location No Information
Date Report to Manufacturer01/25/2019
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? No
Type of Device Usage

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