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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 955596
Device Problems Break (1069); Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/09/2021
Event Type  malfunction  
Manufacturer Narrative
The actual device was not available; however, photographs of the sample were provided for evaluation. Visual inspection of the provided photos was performed and identified that the screwed connector return is cracked. The reported condition was verified. The probable cause of the crack was related to mechanical shock during transportation. 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. Prismaflex st150 set c 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.
 
Event Description
It was reported that during priming with a prismaflex st150 set, unspecified component damage was noted and a leak was observed. There was no patient involvement. 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 Key12760720
MDR Text Key283951633
Report Number8010182-2021-00337
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 11/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955596
Device Lot Number20I2203
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/14/2021
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 Initial

Patient Treatment Data
Date Received: 11/07/2021 Patient Sequence Number: 1
Treatment
NA.
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