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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Device Alarm System (1012); Computer Software Problem (1112)
Patient Problem Insufficient Information (4580)
Event Date 02/10/2021
Event Type  malfunction  
Event Description
While a patient was on crrt (continuous renal replacement therapy) treatment, false pressure parameter alarms sounded. Clinician called nurse and nurse educator into the room to review alarm and assist in trouble shooting. After reviewing the alarms and attempting to troubleshoot, baxter was called for support. Previous documentation of pressure parameters was reviewed but no indication of additional issues except that the circuit was likely clotted off. Decision was made not to return blood to the patient due to risk of clotting. No indications of increased pressure were noted from the documentation. Alarms that were triggered: t1169 return disconnection, t0822 flow problem, t1552 effluent low flow rate, and t1145 check access. Manufacturer response for hemodialysis, prismax (per site reporter): baxter has investigated this and several other machines with the same issues. They believe it is a software issue and is working on updating the entire fleet.
 
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Brand NamePRISMAX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
one baxter parkway
deerfield IL 60015
MDR Report Key11403975
MDR Text Key234476592
Report Number11403975
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 02/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/03/2021
Is this an Adverse Event Report? No
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 FDA02/23/2021
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer03/03/2021
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 Unkown

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