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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX M100 FILTER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX M100 FILTER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Lot Number 21D1305
Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 12/27/2021
Event Type  malfunction  
Event Description
Upon responding to the prismaflex machine alarm, i discovered that one of the pieces of tubing involved in the crrt circuit (the tubing around the effluent pump) had come apart and was leaking effluent fluid down the machine. Due to the tubing being disconnected without being able to reconnect it, the circuit had to be changed without returning blood back to patient. Fda safety report id# (b)(4).
 
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Brand NamePRISMAFLEX M100 FILTER
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
MDR Report Key13236759
MDR Text Key283778401
Report NumberMW5106589
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number21D1305
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Is This a Reprocessed and Reused Single-Use Device? No

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