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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX MACHINES DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955052
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2022
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that approximately four hours into treatment with a prismaflex control unit, a red screen suddenly appeared with no controllability. The treatment was ended without the extracorporeal (ec) blood being returned to the patient. It was reported that at an earlier time on the same day while performing therapy on the same control unit, clotting on the oxiris set was observed and the control unit displayed a red screen followed by the inability to control from the touch screen. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NamePRISMAFLEX MACHINES
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - LUND MONITORS
magistratsvagen 16
lund skane lan SE-22 643
SW SE-22643
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key13824594
MDR Text Key287546179
Report Number9616026-2022-00033
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955052
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1900
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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