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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - BROOKLYN PARK PRISMAX CONTROL UNIT DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE - BROOKLYN PARK PRISMAX CONTROL UNIT DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955558
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Vascular System (Circulation), Impaired (2572)
Event Date 06/11/2019
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that approximately 30-45 minutes into therapeutic plasma exchange (tpe ) treatment using a prismax machine, a patient became circulatory unstable. The operator realized that the tpe had been incorrectly programmed. The patient plasma removal had been set to the same volume as the plasma exchange volume. Per the operator, the treatment prescription in the prismax graphical user interphase was perceived as unclear. Medical intervention included infusion of colloid solution(s) and increase in inotrope medication. At the time of the report, the patient's condition had stabilized. No additional information is available.
 
Manufacturer Narrative
Additional information:the control unit was not received for evaluation. The event history log review showed there was no allegation towards a malfunctioning prismax machine. Based on review of available data, a therapeutic plasma exchange (tpe) was incorrectly programmed. However, the operator must review and confirm the tpe prescription prior to starting treatment and the screen will, among other, display the target effluent volume together with target post filter hematocrit and filtration fraction. Thus, the displayed parameters should have alerted the operator to the programming error. Based on review of available data, the event is related to a use error (programming error). Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NamePRISMAX CONTROL UNIT
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - BROOKLYN PARK
minneapolis MN
Manufacturer (Section G)
BAXTER HEALTHCARE - BROOKLYN PARK
7601 northland drive
n suite 170
minneapolis MN 55428
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8767098
MDR Text Key150250200
Report Number1416980-2019-03641
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number955558
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date06/11/2019
Event Location No Information
Date Manufacturer Received07/31/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/08/2019 Patient Sequence Number: 1
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