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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 Problems Obstruction of Flow (2423); Air/Gas in Device (4062)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/19/2021
Event Type  Injury  
Manufacturer Narrative
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 a prismaflex st150 set clotted during continuous renal replacement therapy following multiple access related alarms generated by the prismax machine. Blood was not returned to the patient and the amount of blood loss was not reported. The patient was reported to have been very unwell and blood transfusion was provided as hemoglobin was 72. A new treatment was initiated but this was also associated with access related problems and air was observed in the extracorporeal circuit at the junction of the pbp line with the access blood line. Attempts to correct the chamber fluid level and clear the alarms were unsuccessful and the prismaflex st150 set clotted. No additional information was provided.
 
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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 Key13472460
MDR Text Key285184204
Report Number8010182-2022-00017
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number107640
Device Lot Number21E2202
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/23/2022
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 Initial

Patient Treatment Data
Date Received: 02/07/2022 Patient Sequence Number: 1
Treatment
PRISMAX MACHINE
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