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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Break (1069); Temperature Problem (3022)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Hypothermia (1915)
Event Date 06/02/2021
Event Type  malfunction  
Event Description
Prismaflex machines have a blood warmer attached to them. This patient is receiving crrt therapy therefore the blood warmer is needed to warm patient blood to prevent patient from becoming hypothermic. Blood warmer reading 43 degrees celsius however the tubing was cold, and the patient temperature dropped to 35. 5 rectally. This caused patient to become bradycardic and hypotensive and experienced hypothermia. Equipment changed out with another heater from another prismaflex machine leaving that one unable to be used. Actions taken to ensure no patient harm. A bair hugger was placed, and fluid resuscitation and pressors (epinephrine and vasopressin drips) were initiated. Patients status improved after these interventions, but given instability of patient overnight, surgery scheduled for this morning was cancelled. Bio-med identified later that the insulated cable that holds the tubing was broken.
 
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Brand NamePRISMAFLEX
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 Key11998860
MDR Text Key256195055
Report Number11998860
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 Risk Manager
Type of Report Initial
Report Date 06/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2021
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? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/10/2021
Event Location Hospital
Date Report to Manufacturer06/15/2021
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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