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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number M150
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 05/07/2021
Event Type  malfunction  
Event Description
Prismaflex machine alarmed "air in blood". Two rns troubleshooted alarm as instructed on screen, decreased return pressure to "return pressure to negative". Patient assessed. Hd line assessed. Tubing and cartridge on prismaflex assessed. Aeration chamber noted to be dry. The chamber was previously assessed with adequate fluid in chamber. "air in blood" alarm continued. Unable to increase fluid in chamber. Machine turned off at this time. Blood was not returned. Clinical supervisor at bedside and updated. The machine was removed from the patient room.
 
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Brand NamePRISMAFLEX SET
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 Key11840648
MDR Text Key251128813
Report Number11840648
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 05/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM150
Device Catalogue Number109990
Device Lot Number20H1203
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/13/2021
Event Location Hospital
Date Report to Manufacturer05/18/2021
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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