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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX TPE; SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX TPE; SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA Back to Search Results
Catalog Number 107144
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/07/2021
Event Type  Death  
Manufacturer Narrative
The information in this mdr was initially submitted to the fda on 10/04/2021 through mdr 8010182-2021-00300.8010182-2021-00300 incorrectly indicated that the report was being submitted as an importer report.This mdr is being resubmitted to the fda as a manufacturer report and 8010182-2021-00300 is being closed as a duplicate of this mdr.Initial reporter phone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during therapeutic plasma exchange with a prismaflex tpe2000 set and a prismaflex control unit, a patient suddenly passes away.It was reported that no alarms were issued by the control unit.The cause of death was not reported.It was not reported if an autopsy was performed.No additional information is available.
 
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Brand Name
PRISMAFLEX TPE
Type of Device
SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA
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 Key12591709
MDR Text Key275221643
Report Number8010182-2021-00302
Device Sequence Number1
Product Code MDP
Combination Product (y/n)Y
Reporter Country CodeSW
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 10/07/2021
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 Number107144
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/07/2021
Initial Date FDA Received10/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
PRISMAFLEX CONTROL UNIT
Patient Outcome(s) Death;
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