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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (M & ST); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (M & ST); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 115307
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/13/2023
Event Type  malfunction  
Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital-china.Initial reporter address: (b)(6).The actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the provided photographic sample, no damage was observed on the male luer lock of the access line.Due to the nature of the provided samples, no further testing could be performed.Therefore, the reported condition was not 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.
 
Event Description
It was reported an external leak was observed originating from a damaged access luer connector of a prismaflex m150 set.The damage was not further specified.The event occurred during an unspecified process step while the patient underwent hemodialysis therapy.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 (M & ST)
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 Key16707675
MDR Text Key312978795
Report Number8010182-2023-00110
Device Sequence Number1
Product Code KDI
UDI-Device Identifier07332414118365
UDI-Public(01)07332414118365
Combination Product (y/n)N
Reporter Country CodeTW
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 04/10/2023
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 Number115307
Device Lot Number22G0027
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/13/2023
Initial Date FDA Received04/10/2023
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
NI.
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