FDA Adverse Event Malfunction Summary report: N

ALARIS® PUMP MODULE ADMINISTRATION SET

MDR report key: 7176997 · Received January 9, 2018

Report

Report Number: 9616066-2018-00026
Event Type: Malfunction
Date Received: January 9, 2018
Date of Event: November 13, 2017
Report Date: November 15, 2017
Manufacturer: CAREFUSION
Product Code: FPA
PMA / PMN Number: K944320
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: 1000ML BAXTER BAG, LOT # Y250092, EXP. APR. 19 / RECEIVED 0.9% SODIUM CHLORIDE INJECTION USP. 250ML BAXTER BAG, LOT # Y245886, EXP. MAR 19 / RECEIVED 0.9% SODIUM CHLORIDE INJECTION USP. THE CUSTOMER¿S REPORT OF A PERCEIVED OVERINFUSION WAS CONFIRMED, DUE TO A CHECK VALVE FAILURE THAT ALLOWED FLUID TO BACKFLOW FROM THE SECONDARY CONTAINER INTO THE PRIMARY CONTAINER. FUNCTIONAL TESTING FOUND THE PUMP MODULE WAS DELIVERING FLUID WITHIN SPECIFICATION. TESTING CONFIRMED BACKFLOW FROM THE SECONDARY CONTAINER INTO THE PRIMARY CONTAINER INDICATING A FAULTY CHECK VALVE IN THE PRIMARY INFUSION SET. THE ROOT CAUSE OF THE PERCEIVED OVERINFUSION WAS A FAULTY CHECK VALVE. THE CAUSE OF THE FAULTY CHECK VALVE IS UNKNOWN.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT A SECONDARY INFUSION OF 250 ML OF VANCOMYCIN (1000MG) WAS PROGRAMMED TO INFUSE AT 130ML/HR (TOTAL VOLUME 285) FOR 2 HOURS HOWEVER AFTER 1 HOUR THE BAG WAS EMPTY. THE SECONDARY SOLUTION WAS PIGGY BACKED TO A PRIMARY SOLUTION OF 1000ML OF SALINE. THE PUMP STATED 129ML INFUSED WHEN THE 250ML BAG WAS NOTED TO BE EMPTY. THERE WAS NO REPORT OF PATIENT HARM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
18342	ALARIS® PUMP MODULE ADMINISTRATION SET	SET, ADMINISTRATION, INTRAVASCULAR	FPA	CAREFUSION	11171447

Patients

Seq	Age	Sex	Outcome	Treatment
1