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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX ST100 BE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 115309
Device Problem Fluid Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 01/20/2021
Event Type  malfunction  
Manufacturer Narrative
Prismaflex st100 set ckt has been temporarily approved for use in the us under emergency use authorization (b)(4)to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic. Initial reporter pone number: (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an external fluid leak was observed on a prismaflex st100 set during priming. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was received for evaluation. A visual inspection, a leak test and a simulated test were performed and the reported condition was not verified. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NamePRISMAFLEX ST100
Type of DeviceBE DIALYZER, 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 60073
2242702068
MDR Report Key11321626
MDR Text Key239595500
Report Number8010182-2021-00048
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeKS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number115309
Device Lot Number20H2901
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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