ACCESS

MDR report key: 4485169 · Received February 4, 2015

Report

Report Number: 1416980-2015-04327
Event Type: Malfunction
Date Received: February 4, 2015
Report Date: January 8, 2015
Manufacturer: BAXTER HEALTHCARE
Product Code: FPA
PMA / PMN Number: K112893
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT SOLUTION FLOWED AT A SLOWER RATE THAN EXPECTED WITH A CLEARLINK SOLUTION SET. THIS OCCURRED DURING FLOW RATE ACCURACY TESTING USING A FLOGARD PUMP WITH THE SET. THE REPORTER STATED THAT THE PUMP WAS "PROGRAMMED WITH A PRIMARY RATE OF 1800 ML/H WITH A VTBI OF 30 ML"; HOWEVER, "THE RESULT WAS A CONSISTENT 24 ML¿S DELIVERED (-20%)." THE PROGRAMMED FLOW RATE WAS THEN DOPPED TO 900, 300, AND 100 ML/HOUR, BUT THE ACTUAL FLOW RATE REMAINED 24 ML/HOUR. THE REPORTER INDICATED THAT THERE WAS NO ISSUE WITH THE PUMP AS DIFFERENT SETS (NON-BAXTER PRODUCTS) PASSED THE TEST WITH THE SAME PUMP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
81883	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE		R14B17103

Patients

Seq	Age	Sex	Outcome	Treatment
1