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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAX SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 955626
Device Problems Filling Problem (1233); Protective Measures Problem (3015)
Patient Problem Insufficient Information (4580)
Event Date 04/15/2021
Event Type  malfunction  
Event Description
The new prismax continuous veno-venous hemofiltration (cvvh) machine was primed and attached to patient without any problems. Shortly after attaching to patient while machine was up and running the deaeration chamber began accumulating foam and the fluid level started dropping quickly. This nurse was watching the chamber very carefully trying to keep it filled to the adequate amount while not allowing the foam to reach the sensor above. The foam continued to accumulate and it set off the sensor causing an alarm which stopped the circuit from running. This nurse tried to return the blood right away but the machine would not allow. Also this all happened very quickly and there was not time to call the machine hotline for help. The blood was not returned to patient and the trauma team was notified as well as nurse educator and charge rn manufacturer response for cvvh machine, prismax system (per site reporter): baxter service engineer came on-site and was not able to duplicate the reported condition. Engineer performed liquid level sensor sst as per manufacturer procedures and it passed. Also, performed simulated therapy with no unexplained alarms. The machine has been returned back into service.
 
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Brand NamePRISMAX SYSTEM
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 Key12084569
MDR Text Key258926651
Report Number12084569
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
Type of Report Initial
Report Date 06/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number955626
Device Catalogue Number955626
Device Lot Number955626
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/21/2021
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer06/29/2021
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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