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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX TPE2000; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX TPE2000; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 107144
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during treatment with a prismaflex tpe2000 set, the alarm for plasmafilter clotting was activated.The session was discontinued and a new set was used to continue treatment and the same issue occurred.There was patient involvement with blood loss due to the two incidents.No additional information was provided.
 
Manufacturer Narrative
The sample was not returned and the lot number of the device was unknown; therefore, a sample analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
PRISMAFLEX TPE2000
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - MEYZIEU
deerfield IL
MDR Report Key9553840
MDR Text Key190162863
Report Number8010182-2019-00224
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number107144
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received01/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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