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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS ST DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955596
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/18/2022
Event Type  malfunction  
Event Description
It was reported that one hour after treatment with a prismaflex st150 set, an external fluid leak from the drain bag was observed. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
Initial reporter facility name: (b)(6). The actual device was not available; however, a photograph and a video of the sample were provided for evaluation. Visual inspection identified an external leak fluid from the drain bag due to a hole in the bag. The reported condition was verified. The cause of the condition was determined to be a manufacturing issue. 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 NamePRISMAFLEX SETS ST
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - MEYZIEU
av lionel terray, b.p. 126
meyzieu cedex rhone 69883
FR 69883
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key14373886
MDR Text Key293176067
Report Number8010182-2022-00122
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955596
Device Lot Number21D2204
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/18/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/12/2022 Patient Sequence Number: 1
Treatment
PRISMAFLEX MACHINE
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