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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF 1000 CRRT FILTER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF 1000 CRRT FILTER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT DIALYSATE SYSTEM Back to Search Results
Model Number 1007173631004827
Device Problem Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/25/2018
Event Type  malfunction  
Event Description
Prior to opening package, nurse noted spike not in place on green dialysate line. Protective caps not in place. Crrt filter set not used on pt.
 
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Brand NamePRISMAFLEX HF 1000 CRRT FILTER
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key7869302
MDR Text Key120137534
Report NumberMW5079755
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 08/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1007173631004827
Device Lot Number18B0801
Was Device Available for Evaluation? No
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?
Type of Device Usage

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