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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 107636
Device Problem Fluid Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 01/03/2021
Event Type  malfunction  
Manufacturer Narrative
Prismaflex st100 set 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. 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 not received for evaluation; however, a picture of the impacted set was provided. The visual inspection of the picture could not identify the reported leak, nevertheless, the reported condition could not be refuted. The cause could not be determined. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an external fluid leak was observed through the effluent transducer (yellow line) on a prismaflex st100 set during priming. There was no patient involvement. No additional information is available.
 
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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 Key11230142
MDR Text Key228682991
Report Number8010182-2021-00013
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeBR
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2022
Device Catalogue Number107636
Device Lot Number20G2006
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 Received01/04/2021
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

Patient Treatment Data
Date Received: 01/26/2021 Patient Sequence Number: 1
Treatment
NA.
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