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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
Device Problem Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 02/13/2020
Event Type  malfunction  
Event Description
During continuous renal replacement therapy (crrt) treatment, dialysis machine unexpectedly quit. Attempted to call baxter, but was placed on hold for 10 minutes. Followed instructions on screen, and attempted to manually return blood, but unable to. Disconnected patient from machine and ended treatment. This has been given to the davita admin lead to let their biomed department check out the machine and see if there was any specific issue with the machine. This device was a davita rental - clinical engineering tech calibrated scale, put through alarm & pressure test on rental prismflex dialysis machine. Machine was verified functional - returned to service.
 
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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 Key12016362
MDR Text Key256724334
Report Number12016362
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 06/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/09/2021
Event Location Hospital
Date Report to Manufacturer06/17/2021
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?
Type of Device Usage Unkown

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