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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 Break (1069); Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone number: (b)(6). The device was not received for evaluation; however, a picture of the impacted set was provided. The visual inspection observed that the cone of the return male luer lock was broken. The reported condition was verified. The cause is design related. A nonconformance has been opened to address this issue. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an external fluid leak was observed on a prismaflex m100 set during priming. The leak was due to a damaged luer connector. There was no patient involvement. 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 
2242702068
MDR Report Key11565309
MDR Text Key242205944
Report Number8010182-2021-00111
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeCH
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2022
Device Catalogue Number955595
Device Lot Number20I0204
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2021
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 Unkown

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