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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 107493
Device Problems No Audible Alarm (1019); No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2019
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during continuous renal replacement therapy (crrt) using a prismaflex control unit, the ¿machine fails to flow and no alarm sound¿ was generated. 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
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 22643
SW 22643
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key9406538
MDR Text Key169023854
Report Number9616026-2019-00061
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/03/2019,12/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number107493
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/03/2019
Event Location Hospital
Date Report to Manufacturer12/03/2019
Date Manufacturer Received12/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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