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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAX CRRT MACHINE/BAXTER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAX CRRT MACHINE/BAXTER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problem Defective Device (2588)
Patient Problems Vascular System (Circulation), Impaired (2572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/23/2020
Event Type  Injury  
Event Description
On (b)(6) 2020. Delay in our ability to provide life-saving treatment of crrt contributed to continued decompensation of physiologic and hemodynamic stability, and worsening acid-base balance in this patient. A temporary hd catheter was placed at approx. (b)(6) at 2350. Crrt was to be initiated immediately to treat acute renal failure. Both prismax crrt machines, our machine and a baxter loaner machine displayed alarm "b1215 arps system failed". This alarm is a red alarm and would not allow for priming of the set and treatment could not be started. Both machines were turned off and attempts to reload the filter cartridge were made multiple times with the same alarm. I also attempted to use the manual tool on the back to override the alarm. Baxter icon line was called to determine if issue could be remedied. Baxter rep insisted that both machines be removed from service as this alarm signaled that an internal hardware issue was present. I requested that a stat service ticket be placed and stressed the importance of treatment for this patient. I requested that the loaner department be emergently paged to determine if an alternate machine could be delivered. The loaner department was unable to provide a loaner and stated that none were immediately available in the dfw area. Fda safety report id # (b)(4).
 
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Brand NamePRISMAX CRRT MACHINE/BAXTER
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
MDR Report Key10958701
MDR Text Key220247345
Report NumberMW5098231
Device Sequence Number1
Product Code KDI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/02/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/04/2020 Patient Sequence Number: 1
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