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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX M100 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 106697
Device Problems Fluid Leak (1250); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/10/2020
Event Type  malfunction  
Manufacturer Narrative
Facility name: (b)(6). Address: (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that upon starting treatment with a prismaflex m100, a leak was observed. Treatment was stopped and the filter was changed. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NamePRISMAFLEX M100
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 Key10824485
MDR Text Key225552158
Report Number8010182-2020-00246
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K041005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/11/2020,12/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Catalogue Number106697
Device Lot Number20F0602
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/11/2020
Distributor Facility Aware Date10/19/2020
Event Location Other
Date Report to Manufacturer11/11/2020
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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