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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS, INC. PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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GAMBRO RENAL PRODUCTS, INC. PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 107493
Device Problems No Display/Image (1183); Failure to Power Up (1476); Unexpected Shutdown (4019)
Patient Problem Insufficient Information (4580)
Event Date 04/21/2021
Event Type  malfunction  
Event Description
Prisma was running normally and shut down without warning. Screen turned black and alarm beeping. Could not turn on again. Had to immediately disconnect the patient from the machine to prevent clotting of the lines.
 
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Brand NamePRISMAFLEX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO RENAL PRODUCTS, INC.
one baxter parkway
deerfield IL 60015
MDR Report Key11831227
MDR Text Key250841105
Report Number11831227
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 04/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number107493
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/27/2021
Event Location Hospital
Date Report to Manufacturer05/17/2021
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? No
Type of Device Usage Unkown

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