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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX ST100 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX ST100 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955468
Device Problems Break (1069); Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2021
Event Type  malfunction  
Event Description
It was reported that during treatment with a prismaflex st100, an external blood leak was observed due to a broken component. There was patient involvement but no patient impact and no medical intervention. No additional information is available.
 
Manufacturer Narrative
Initial reporter phone no. (b)(6). Prismaflex st100 set c has been temporarily approved for use in the us under emergency use authorization eua (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NamePRISMAFLEX ST100
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
7, 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 Key12849948
MDR Text Key283773603
Report Number8010182-2021-00352
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,Followup
Report Date 01/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955468
Device Lot Number21B2402
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2022
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: 11/21/2021 Patient Sequence Number: 1
Treatment
NI.
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