FDA Adverse Event Malfunction Summary report: N

CLEARLINK DUO-VENT C-FLO SET10 DPM DUO-VENT

MDR report key: 1932608 · Received December 19, 2010

Report

Report Number: 6000001-2010-06011
Event Type: Malfunction
Date Received: December 19, 2010
Date of Event: June 23, 2010
Report Date: June 23, 2010
Manufacturer: BAXTER HEALTHCARE
Product Code: FPA
PMA / PMN Number: K961225
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE OF A NO FLOW THAT OCCURRED WITH THE CLEARLINK DUO-VENT CONTINU-FLO SET DURING PATIENT USE. THE PATIENT WAS SET TO RECEIVE AN UNKNOWN ANTIBIOTIC WITH A 50 ML SECONDARY BAG. THE PRIMARY BAG WAS A 1000 ML BAG OF NORMAL SALINE. THE NURSE WAS USING A COLLEAGUE SINGLE CHANNEL PUMP WITH THIS SETUP. THE NURSE DID NOT SQUEEZE THE BAG TO INITIATE FLOW. THE NURSE DID NOT INVERT AND TAP THE CHECK VALVE TO PURGE THE AIR. PER THE CUSTOMER, THEY HAVE NEVER HEARD OF EITHER OF THESE TECHNIQUES. THE SECONDARY SET IS THE SET THAT DEMONSTRATED THE NO FLOW. THE DRIP CHAMBER WAS NOT FLOODED OR FULL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CLEARLINK DUO-VENT C-FLO SET10 DPM DUO-VENT	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1				1000ML BAG OF NORMAL SALINE\| 50ML BAG OF AN UNKNOWN ANTIBIOTIC\| SET, ADMINISTRATION, INTRAVASCULAR