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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 955595
Device Problems Disconnection (1171); Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2021
Event Type  malfunction  
Event Description
It was reported that 2-3 hours into treatment with a prismaflex m100 set c, an external fluid leak was observed due to a separation of the effluent clamp. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
Initial reporter facility name: (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
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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 
2242702068
MDR Report Key13476514
MDR Text Key285224303
Report Number8010182-2022-00019
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955595
Device Lot Number21F2107CB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/07/2022 Patient Sequence Number: 1
Treatment
NI.
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