FDA Adverse Event Injury Summary report: N

AMICUS SEPARATOR SYSTEM

MDR report key: 3736082 · Received April 4, 2014

Report

Report Number
3004548776-2014-00002
Event Type
Injury
Date Received
April 4, 2014
Date of Event
March 14, 2014
Report Date
March 4, 2014
Manufacturer
FENWAL, INC.
Product Code
GKT
PMA / PMN Number
K111702
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THE PT IS UNDERGOING TPE PROCEDURES DUE TO A REJECTED KIDNEY TRANSPLANT. THIS SAME PT HAS UNDERGONE APPROXIMATELY 10 TPE PROCEDURES ON THE AMICUS DEVICE. FOR THIS PARTICULAR PROCEDURE, THE OPERATOR CHANGED THE TARGET FLUID BALANCE FROM 100% TO 90% AFTER 550ML OF WHOLE BLOOD (WB) PROCESSED. THE OPERATOR FURTHER ADJUSTED THE TARGET FLUID BALANCE FROM 90% TO 80% WITHIN MINUTE OF THE FIRST ADJUSTMENT. AN 80% TARGET FLUID BALANCE EQUATES TO LEAVING THE PT HYPOVOLEMIC BY 20% OF THEIR TOTAL BLOOD VOLUME. THE PT HAS PERIPHERAL ACCESS AND WAS SHOWING SIGNS OF INLET LINE OCCLUSIONS. IT IS LIKELY THAT THE OPERATOR INTENDED TO CHANGE THE MAXIMUM WB FLOW RATE, BUT CHANGED THE TARGET FLUID BALANCE INSTEAD. THE MACHINE DID AS INSTRUCTED BY THE OPERATOR AND TARGETED 80% FOR FLUID BALANCE WHICH LED TO THIS INCIDENT. THE NURSE TOLD THE FSE THAT IT WAS VERY LONG DAY AND THIS PROCEDURE AS AROUND 7 PM, SO SHE WAS VERY TIRED. THE PT FAINTED AT THE END OF THE PROCEDURE, HE HAD A BLOOD PRESSURE AT THAT MOMENT OF 65/40. THE TREATMENT THE NURSE GAVE WAS A SALINE SOLUTION BOLUS OF TWO UNITS (TOTAL 1000ML) WITH A RECOVERY BLOOD PRESSURE OF 90/48. AFTER RECOVERY THE PERSON LEFT THE HOSPITAL ASYMPTOMATIC. IT HAS BEEN DIFFICULT FOR FENWAL'S RISK MGR TO SPEAK DIRECTLY TO THE PT; HOWEVER, THE NURSE SPOKE TO HIS WIFE AND SHE STATED HE IS FINE AND WILL GO TO THE NEXT SCHEDULED TOTAL PLASMA EXCHANGE (TPE) TREATMENT ON THE AMICUS MACHINE BECAUSE HE TRUSTS THE AMICUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
204710 AMICUS SEPARATOR SYSTEM AUTOMATED BLOOD CELL SEPARATION GKT FENWAL, INC. 4R4580 NA

Patients

Seq Age Sex Outcome Treatment
1 Life Threatening