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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO AB PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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GAMBRO AB PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 5.XX
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 11/01/2021
Event Type  malfunction  
Event Description
Crrt (continuous renal replacement therapy) pump alarmed ¿malfunction: blood pump¿. Interventions on screen performed and checked. Therapy was restarted. The pump alarmed again ¿malfunction: blood pump¿. The lines and blood pump were assessed. The alarm could not be cleared. The blood was given back. The pump and circuit were changed, and treatment continued.
 
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Brand NamePRISMAFLEX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO AB
one baxter parkway
deerfield IL 60015
MDR Report Key13076468
MDR Text Key282722133
Report Number13076468
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 Other Health Care Professional
Type of Report Initial
Report Date 12/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5.XX
Device Catalogue Number113081
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/03/2021
Event Location Hospital
Date Report to Manufacturer12/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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