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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO DASCO SPA PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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GAMBRO DASCO SPA PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number PHOENIX
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem Insufficient Information (4580)
Event Date 03/29/2021
Event Type  malfunction  
Event Description
Patient was running dialysis and machine went into 320 alarm generals system failure. The patient was rinsed back manually. The machine was changed out. A work order was called to biomed. Manufacturer response for hemodialysis unit, baxter - gambro (per site reporter). Staff stated error 320 general system failure. When i powered up unit, it gave same error. A hose was noticed to have came off out of the 90 degree elbow off the back of the po transducer and was leaking down onto the sterilant pumps. Replaced elbow and found that the puf had significant water leaked onto it. I unplugged puf pump and powered unit on and it did not error. So, i replaced the puf pump with a new one. Ran rinse because unit shut down during treatment it kept trying to find old treatment parameters. Called baxter and they said my diagnosis and repair was correct and if it passed patient simulation to return it back to use. Ran patient sim successfully. Ran bleach and rinse and returned to use.
 
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Brand NamePHOENIX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO DASCO SPA
one baxter parkway
deerfield IL 60015
MDR Report Key11684817
MDR Text Key245997282
Report Number11684817
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 03/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPHOENIX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/31/2021
Event Location No Information
Date Report to Manufacturer04/19/2021
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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