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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. PRISMAFLEX M100 FILTER SET CONTINUOUS DIALYSIS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORP. PRISMAFLEX M100 FILTER SET CONTINUOUS DIALYSIS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 106697
Device Problems Break (1069); Fluid Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 01/24/2021
Event Type  malfunction  
Event Description
His patient had been on crrt since 0200 on (b)(6) 2021. At 1700 rn walked into patients room and noticed a large amount of bright red blood on the crrt machine and on the floor in front of the machine. There were no alarms associated with this event from the machine. The crrt machine was immediately paused for investigation. Rn discovered the tube that connects to the top of the filter was broken off the filter. This was noted to have happened 20 minutes prior to discovery since rn had been in the room performing the other task prior. There was also, a large amount of air noted in the tubing therefore the crrt machine was disconnected without the 150cc blood return. Ther had not been any significant changes to the settings on the machine or the fluid removal rate from the settings that it had been running the entire shift. There does not seem to be any harm to the patient and there was no visible air in the lines that were closest to the connection of the patient, only in the prefilter lines. New filter set was placed and crrt ran without complications.
 
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Brand NamePRISMAFLEX M100 FILTER SET CONTINUOUS DIALYSIS
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORP.
MDR Report Key11251027
MDR Text Key229603282
Report NumberMW5099093
Device Sequence Number1
Product Code KDI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Personal Care Assistant
Type of Report Initial
Report Date 01/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number106697
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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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