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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 115309
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/11/2021
Event Type  malfunction  
Manufacturer Narrative
Prismaflex st100 set ckt 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.
 
Event Description
It was reported that during treatment with a prismaflex st100, air was observed in the set and the blood was clotted. Two sets were replaced due to this event. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
The device was not received for evaluation, however two pictures were received. The visual inspection observed air in the blood circuit. The reported condition was verified. 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 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 60073
2242702068
MDR Report Key11273981
MDR Text Key241972111
Report Number8010182-2021-00030
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
Type of Report Initial,Followup
Report Date 03/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2022
Device Catalogue Number115309
Device Lot Number20H1201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2021
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 Unkown

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