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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FENWAL INC. AMICUS SEPARATOR SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
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FENWAL INC. AMICUS SEPARATOR SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC Back to Search Results
Model Number 4R4580
Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2018
Event Type  malfunction  
Event Description
Patient was receiving therapeutic plasma exchange (tpe).With approximately 5 minutes left on treatment, the machine alarmed centrifuge leak.Treatment was immediately stopped.The patient was disconnected from the machine without returning patient's blood.Stat hemoglobin and hematocrit (h&h) was drawn and physician was notified.Vital signs were assessed and were stable.Patient was stable upon leaving unit.The machine was taken out of service and cassette was placed in red bag.Fenwal notified of centrifuge leak.Fenwal technician scheduled to look at machine and cassette.
 
Event Description
Patient was receiving therapeutic plasma exchange (tpe).With approximately 5 minutes left on treatment, the machine alarmed centrifuge leak.Treatment was immediately stopped.The patient was disconnected from the machine without returning patient's blood.Stat hemoglobin and hematocrit (h&h) was drawn and physician was notified.Vital signs were assessed and were stable.Patient was stable upon leaving unit.The machine was taken out of service and cassette was placed in red bag.Fenwal notified of centrifuge leak.Fenwal technician scheduled to look at machine and cassette.
 
Event Description
Patient was receiving therapeutic plasma exchange (tpe).With approximately 5 minutes left on treatment, the machine alarmed centrifuge leak.Treatment was immediately stopped.The patient was disconnected from the machine without returning patient's blood.Stat hemoglobin and hematocrit (h&h) was drawn and physician was notified.Vital signs were assessed and were stable.Patient was stable upon leaving unit.The machine was taken out of service and cassette was placed in red bag.Fenwal notified of centrifuge leak.Fenwal technician scheduled to look at machine and cassette.
 
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Brand Name
AMICUS SEPARATOR SYSTEM
Type of Device
SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
Manufacturer (Section D)
FENWAL INC.
3 corporate dr ste 300
lake zurich IL 60047
MDR Report Key8435880
MDR Text Key139332495
Report Number8435880
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup,Followup
Report Date 03/11/2019,12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4R4580
Device Lot NumberFA18D10092
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/11/2019
Event Location Hospital
Date Report to Manufacturer03/20/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/20/2019
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received03/20/2019
03/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age21170 DA
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