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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (OXIRIS); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (OXIRIS); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955540
Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2023
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address:(b)(6).Initial reporter city.Oxiris c is similar to oxiris and oxiris s.Oxiris and oxiris s have been temporarily approved for use in the us under emergency use authorization (b)(4) with a specific indication to treat patients with covid-19 infection.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the provided photographic samples, the cone of the access male luer lock (mll) is broken.The reported condition was verified.Due to the nature of the provided sample, no further testing could be performed; therefore, the cause of the condition could not be determined.However, the most probable cause of the leak is likely due to a broken mll cone.These components are provided to the manufacturing plant already assembled by our supplier.A nonconformance has been opened to address this issue.Within in the nonconformance an investigation was performed allowing to identify that this event is due to: the presence of liquid on the mll cone or in the female luer lock (fll) before connection (e.G., use of disinfectant or drop of priming solution, drop of dialysate solution) which lubricates the connection.An improper connection handling (using the body of mll fistula and/or fll components for tightening the connection instead of screwing the coupling nut).Mll design or a combination of these factors can lead to an overtightening of the luer connection which can lead to blocked connection and/or cracks which can cause subsequent leakages.Design change control of the mll ongoing.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.
 
Event Description
It was reported a oxiris c set leaked due to a loose connection.After approximately five minutes into hemodialysis therapy, the unspecified hemodialysis machine alarmed an unknown air alarm.The nurse observed air bubbles ¿continuously entering the connection of the red end¿.The nurse returned the extracorporeal blood, then disconnected the line.The nurse ¿confirmed that the connection of the red end was not tightly sealed¿.The set was unusable due to a crack in the male lock of the access line and was replaced.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
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Brand Name
PRISMAFLEX SETS (OXIRIS)
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 60073
2242702068
MDR Report Key16923797
MDR Text Key315134348
Report Number8010182-2023-00157
Device Sequence Number1
Product Code KDI
UDI-Device Identifier07332414124090
UDI-Public(01)07332414124090
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
Report Date 05/12/2023
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 Catalogue Number955540
Device Lot Number22J0072
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/16/2023
Initial Date FDA Received05/12/2023
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
UNSPECIFIED HEMODIALYSIS MACHINE
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