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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (ST); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955468
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anemia (1706); Thrombocytopenia (4431)
Event Date 10/27/2023
Event Type  Injury  
Manufacturer Narrative
E1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a patient was receiving continuous renal replacement therapy (crrt) using a prismaflex st100 set.It was further reported the patient experienced progressive platelet decline for three days.According to the reporter, a progressive decrease in hemoglobin and a gradual decrease in blood pressure were observed.The patient received a red cell transfusion and crrt was suspended.No additional information is available.
 
Manufacturer Narrative
H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
PRISMAFLEX SETS (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 Key18645383
MDR Text Key334610759
Report Number8010182-2024-00036
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
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 03/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number955468
Device Lot Number22L0057CB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/09/2024
Initial Date FDA Received02/05/2024
Supplement Dates Manufacturer Received02/27/2024
Supplement Dates FDA Received03/11/2024
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
SODIUM CITRATE
Patient Outcome(s) Required Intervention;
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