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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX M100 SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX M100 SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 106697
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 12/04/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during priming with a prismaflex m100 set, a leak occurred at the "exit of the dialyzer". The set was changed to continue. There was no patient involvement. No additional information is available.
 
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Brand NamePRISMAFLEX M100 SET
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 60073
2242702068
MDR Report Key11077981
MDR Text Key224356483
Report Number8010182-2020-00317
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeVM
PMA/PMN Number
K041005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2021
Device Catalogue Number106697
Device Lot Number19K2801
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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