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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 114093
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967); Nausea (1970); Vomiting (2144); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/16/2022
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that within the first few minutes of therapeutic plasma exchange with a prismaflex tpe2000, a blood leak detector alarm was triggered and an internal blood leak was identified. Visible blood tinged effluent was observed in the effluent line and the drain bag. Visible blood was also observed on the outside of the filter semi-permeable membrane fibers. Treatment was stopped without blood return. A total of 125ml of blood was lost. The patient was stable and the vital signs were normal. Within twenty (20) minutes of starting a new tpe treatment the patient became pale and presented with weakness, nausea and vomiting. The blood pressure reading was 84/43 mmhg. The patient was treated with an unspecified amount of saline. The patient reported they were not feeling well and treatment was interrupted with blood return and another 30 ml saline was provided. The patient 's condition subsequently improved, and the blood pressure increased to 110/60 mmhg. Tpe treatment was suspended for the day. 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 Key13970927
MDR Text Key288786129
Report Number8010182-2022-00085
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PMA P830063
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114093
Device Lot Number21D1404
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/31/2022 Patient Sequence Number: 1
Treatment
NI.
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