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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Fluid Leak (1250); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/25/2020
Event Type  malfunction  
Manufacturer Narrative
The alleged product was an unknown prismaflex set. The actual device was not available; however, a photograph of the sample was provided for evaluation. The visual inspection of the provided picture confirmed that the cone of the male luer lock of the effluent line was cracked and stuck in the female luer lock of the effluent bag. The reported condition was verified. The cause was manufacturing 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 during treatment with a prismaflex set, the luer connector of the effluent bag was occluded with a plastic piece, which did not allow total amount of effluent into the bag. Small amounts of leakage were visible outside of the bag. Upon changing the effluent bag, large amounts of effluent came from effluent line. There was no patient injury or medical intervention associated with this event.
 
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Brand NameNI
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 69883
FR 69883
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key10380439
MDR Text Key202268745
Report Number8010182-2020-00123
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/07/2020
Distributor Facility Aware Date07/14/2020
Event Location Hospital
Date Report to Manufacturer08/07/2020
Date Manufacturer Received07/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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