FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 2981541 · Received February 27, 2013

Report

Report Number: 1416980-2013-04859
Event Type: Malfunction
Date Received: February 27, 2013
Report Date: February 4, 2013
Manufacturer: BAXTER HEALTHCARE
Product Code: HRX
PMA / PMN Number: K960787
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE ARRIVED OUT OF THE POUCH AND FULLY PRIMED. THE SAMPLE WAS SPIKED INTO AN IN-HOUSE 1000ML SOLUTION BAG CONTAINING REVERSE OSMOSIS WATER. THE SAMPLE WAS THEN RE-PRIMED AND CHECKED FOR FLOW AND THE CLAMP SHUTOFF. THE SAMPLE PRIMED AND FLOWED NORMALLY WITH NO RESTRICTIONS NOTED. ALL CLAMPS SHUT OFF COMPLETELY. ADDITIONALLY: THE SAMPLE WAS VISUALLY INSPECTED FOR KINKED TUBING OR ANY OTHER OBVIOUS VISUAL DEFECTS. NO KINKED TUBING OR OTHER VISUAL DEFECTS WERE FOUND. THE CUSTOMER REPORTED CONDITION WAS NOT CONFIRMED DURING VISUAL INSPECTION OR FUNCTIONAL TESTING. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING SURGERY A Y-TYPE TUR IRRIGATION SET WAS OBSERVED TO HAVE RESTRICTED FLOW AFTER THE SET WAS ATTACHED TO A BAG AND THE SET WAS PRIMED NORMALLY, WHEN THE USER REMOVED THE Y-TYPE IRRIGATION SET AND REPLACED IT WITH A "FULL LEAD" THE FLOW WAS OBSERVED TO RETURN TO NORMAL. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
83700	ACCESS	ARTHROSCOPE	HRX	BAXTER HEALTHCARE		R12I01062

Patients

Seq	Age	Sex	Outcome	Treatment
1				0.9% SODIUM CHLORIDE IRRIGATION, 3000ML