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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 114870
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/19/2022
Event Type  malfunction  
Event Description
It was reported during preparation the wheel of a prismaflex machine was observed to be damaged. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
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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 Key14059651
MDR Text Key291952311
Report Number9616026-2022-00038
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCO
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 05/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number114870
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/28/2022
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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