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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRIMAFLEX CRRT MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Fluid Leak (1250); Detachment of Device or Device Component (2907)
Patient Problems Death (1802); Exsanguination (1841)
Event Date 09/22/2020
Event Type  Death  
Event Description
Patient on crrt. Nurse assessed pt and returned about 1 min later to find pt agonally breathing. Nurse pulled back sheets/bair hugger, and found pt covered in blood. Nurse found blue port to be loose and leaking blood at connection site. Nurse pulled code button. Icu team arrived at bedside and assessed pt. Stopped crrt machine. Increased dopamine infusion to 20. Started 2 l nss via pump at 999 ml/hr. Increased hfnc to 15 lpm and sent rt for nrb. Noted weak dopplered carotid pulse and agonal respirations. Pupils fixed and dilated. Pt in pea arrest. Residents declared time of death at 0830. Fda safety report id# (b)(4).
 
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Brand NamePRIMAFLEX CRRT MACHINE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
MDR Report Key10606905
MDR Text Key209193515
Report NumberMW5096970
Device Sequence Number1
Product Code KDI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/30/2020 Patient Sequence Number: 1
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