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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX M150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE CORPORATION PRISMAFLEX M150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955467
Device Problems Disconnection (1171); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/23/2022
Event Type  malfunction  
Event Description
It was reported that after one hour of treatment with a prismaflex m150 set c, an external fluid leak was observed due to a separated drain bag stopcock.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Facility name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Facility name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that after one hour of treatment with a prismaflex m150 set c, an external fluid leak was observed due to a separated drain bag stopcock.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
The actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the pictures showed that the stopcock of the drain bag was disconnected.The reported condition was verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
PRISMAFLEX M150
Type of Device
DIALYZER, 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 Key13560518
MDR Text Key285950483
Report Number8010182-2022-00037
Device Sequence Number1
Product Code KDI
UDI-Device Identifier07332414123451
UDI-Public(01)07332414123451
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 Nurse
Type of Report Initial,Followup
Report Date 03/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2023
Device Catalogue Number955467
Device Lot Number21J0101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/06/2022
Initial Date FDA Received02/18/2022
Supplement Dates Manufacturer Received02/25/2022
Supplement Dates FDA Received03/04/2022
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 Sequence Number1
Treatment
NI.
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