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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO BY BAXTER DIALYZSER HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM PRISMAFLEX MACHINE

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GAMBRO BY BAXTER DIALYZSER HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM PRISMAFLEX MACHINE Back to Search Results
Model Number 007-00254
Device Problem Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2018
Event Type  malfunction  
Event Description
Crrt machine had power failure, turned off by itself during crrt cycle.
 
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Brand NameDIALYZSER HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Type of DevicePRISMAFLEX MACHINE
Manufacturer (Section D)
GAMBRO BY BAXTER
MDR Report Key7323212
MDR Text Key102074899
Report NumberMW5075752
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number007-00254
Device Lot Number10560
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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