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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAXPRISMAX SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 955626
Device Problems Failure of Device to Self-Test (2937); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/28/2020
Event Type  malfunction  
Event Description
Machine exhibited arps self-test failure on setup. Machine was being set up during rn training class -- not during patient care. Baxter educator reported problem to baxter service team. Upon replacement of arps tubing by baxter field tech, machine also failed return port negative pressure leak test -- return pressure port faulty and also needed to be replaced. Manufacturer response for continuous renal replacement therapy machine, prismaflex system for critical care (per site reporter). Baxter sales rep discussed issue with (b)(4). Baxter rep stated that faulty arps tubing noted to be source of problem, but stated that baxter would not repair machines until device exhibited yet another failure. However, due to safety concerns regarding potential failure while running on patient, icu leadership pulled machines from service. (b)(4) emailed service rep stating that zsfg expects all machines to be proactively repaired prior to putting back in service; awaiting response from baxter.
 
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Brand NamePRISMAXPRISMAX 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 Key11036234
MDR Text Key222313202
Report Number11036234
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 11/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number955626
Device Catalogue 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 FDA11/25/2020
Device Age1 MO
Event Location Hospital
Date Report to Manufacturer12/18/2020
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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