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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS, INC. PRISMAFLEX; DIALYZER, HIGH PERMEABILITY
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GAMBRO RENAL PRODUCTS, INC. PRISMAFLEX; DIALYZER, HIGH PERMEABILITY Back to Search Results
Model Number M150
Device Problem Gas/Air Leak (2946)
Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)
Event Date 01/09/2019
Event Type  malfunction  
Event Description
Patient on ecmo and continuous renal replacement therapy (crrt); filter currently in use suddenly pulled two feet of air from patient to crrt filter.The patient had increased tachycardia (heart rate 120's) and hypotension (systolic blood pressure 80's).The crrt immediately stopped, line checked for blood return, and flushed without any presence of air.Patient's blood pressure stabilized with titrations of vasopressin and phenylephrine infusions (already hanging prior to event).Rn "a" was primary nurse during this event, who had assistance with crrt filter takedown.Physicians notified, with no new orders received.New crrt machine and filter primed and restarted with no issue.
 
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Brand Name
PRISMAFLEX
Type of Device
DIALYZER, HIGH PERMEABILITY
Manufacturer (Section D)
GAMBRO RENAL PRODUCTS, INC.
one baxter parkway
deerfield IL 60015
MDR Report Key8539288
MDR Text Key142746498
Report Number8539288
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 04/16/2019,02/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberM150
Device Catalogue Number109990
Device Lot Number18A0902
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/16/2019
Date Report to Manufacturer04/23/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age13870 DA
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