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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION M100 FILTER DIALYZER, HIGH PERMEABILITY, DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION M100 FILTER DIALYZER, HIGH PERMEABILITY, DIALYSATE SYSTEM Back to Search Results
Lot Number 1881203
Device Problem Entrapment of Device (1212)
Patient Problem No Code Available (3191)
Event Date 06/01/2018
Event Type  Injury  
Event Description
M100 crrt deaeration chamber found to have pieces of fiberglass looking material clogging the chamber. Color and consistency similar to filter material. Concern raised regarding materials migrating to pt. Crrt therapy was interrupted/restarted to change the filter and tubing. Nephrology was notified of the issue and order to change filter size to m150 promptly.
 
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Brand NameM100 FILTER
Type of DeviceDIALYZER, HIGH PERMEABILITY, DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key7586525
MDR Text Key110746689
Report NumberMW5077728
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 06/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number1881203
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/08/2018 Patient Sequence Number: 1
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