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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX M150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE CORPORATION PRISMAFLEX M150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955467
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 11/17/2020
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 priming with a prismaflex m150, an external fluid leak was observed at the filter connector.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection did not observe the location of the fluid leak nor any specific issue on the set.The reported condition was confirmed based on consumer report.The cause could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
PRISMAFLEX M150
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10990556
MDR Text Key224590019
Report Number8010182-2020-00293
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number955467
Device Lot Number19K1903
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/18/2020
Initial Date FDA Received12/11/2020
Supplement Dates Manufacturer Received12/29/2020
Supplement Dates FDA Received01/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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