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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX TPE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 107144
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Low Oxygen Saturation (2477)
Event Date 10/25/2021
Event Type  Injury  
Manufacturer Narrative
Initial reporter address: (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that 25 minutes after starting therapeutic plasma exchange treatment using a prismaflex tpe set, the patient experienced breathing difficulties with drop in oxygen (o2) saturation to 87%. It was reported the patient required the administration of 4 l / min of o2 for the event. Treatment was discontinued. It was reported the set was not replaced and the blood circuit was not returned to the patient. The volume of the plasma exchange set was 1l. It was reported the symptoms improved about 35 minutes later and treatment was continued. No additional information is available.
 
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Brand NamePRISMAFLEX TPE
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 cedex rhone 69883
FR 69883
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12934528
MDR Text Key281754218
Report Number8010182-2021-00377
Device Sequence Number1
Product Code KDI
UDI-Device Identifier07332414069339
UDI-Public(01)07332414069339
Combination Product (y/n)N
Reporter Country CodeFR
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 Pharmacist
Type of Report Initial,Followup
Report Date 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number107144
Device Lot Number21G0103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/06/2021 Patient Sequence Number: 1
Treatment
VIALEBEX 40 MG/ML (REPLACEMENT PLASMA)
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