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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/17/2019
Event Type  malfunction  
Event Description
Prismaflex unit stops and displays error message during treatment: "malfunction: communication error". First occurrence happened a few weeks ago and delayed treatment for 5 hours. Second occurrence happened last week and instructions attached to machine were followed, but still extended treatment by several hours as the nurse had to cycle power several times. Hospital owns 8 prismaflex units. Half were upgraded to the required 7. 20 sw version last year and now are having this issue. The field service engineer has started to install 7. 21 on the units with 7. 20. Manufacturer response for dialysis unit, prismaflex (per site reporter). Have made calls and sent emails. Manufacturer is aware but does not have a solution. Problem began after sw upgrades to 7. 20 and now field service engineer is upgrading to 7. 21.
 
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Brand NamePRISMAFLEX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
25212 w. illinois
route 120
round lake, IL 60073
MDR Report Key8330505
MDR Text Key135859059
Report Number8330505
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2019
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/08/2019
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer02/12/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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