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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX ST150 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX ST150 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 107640
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
Prismaflex st150 set 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. Initial reporter phone number: (b)(6). 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, photos and a video were provided. The visual inspection observed an external fluid leak from the return luer lock. The reported condition was verified. The cause could not be determined. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that upon connecting a prismaflex st150 set, an external fluid leak with a minimal amount of blood was observed at the venous connection point of the line. He blood loss was reported to be less than 150 ml. There was patient involvement however, no patient injury or medical intervention was reported with this event. No additional information is available.
 
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Brand NamePRISMAFLEX ST150
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 Key11385190
MDR Text Key247041651
Report Number8010182-2021-00065
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeCO
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 02/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2022
Device Catalogue Number107640
Device Lot Number20G0204
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 Received02/22/2021
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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