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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 Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/24/2020
Event Type  malfunction  
Manufacturer Narrative
Initial reporter postal code: (b)(6). Prismaflex st150 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. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that after reconnecting the patient for continuous renal replacement therapy using a prismaflex st 150 set, the return line was ¿gushing out from behind the blue screw/leur lock-opposite to the side where the blue luer lock was attached to the permacath lumen¿. Treatment was stopped and it was noted air was in the return line. The extracorporeal (ec) blood was not returned to the patient. There was no patient injury or medical intervention associated 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 60073
2242702068
MDR Report Key11088948
MDR Text Key224358164
Report Number8010182-2020-00323
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeAS
PMA/PMN Number
NA
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 02/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Catalogue Number107640
Device Lot Number20E0303
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 Received02/03/2021
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 Initial

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