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U.S. Department of Health and Human Services

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

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GAMBRO INDUSTRIES PRISMAFLEX SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number M100
Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)
Patient Problems Bradycardia (1751); Asystole (4442)
Event Date 09/05/2021
Event Type  Injury  
Event Description
"crrt set was changed and restarted and patient immediately shut ecmo pump off. Ecmo pump read, "air bubble detected. " patient became bradycardic and then asystolic. Cpr started which lasted ~1 min. Return of spontaneous circulation achieved. Crrt terminated at this time. " per nursing and ecmo team, the filter has more air bubbles in these sets than normal.
 
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Brand NamePRISMAFLEX SET
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO INDUSTRIES
one baxter parkway
deerfield IL 60015
MDR Report Key12540516
MDR Text Key273652145
Report Number12540516
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 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM100
Device Catalogue Number106697
Device Lot Number21E2102
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/10/2021
Event Location Hospital
Date Report to Manufacturer09/28/2021
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

Patient Treatment Data
Date Received: 09/28/2021 Patient Sequence Number: 1
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