FDA Adverse Event Malfunction Summary report: N

UV FLASH TRANSFER SETS

MDR report key: 3961196 · Received July 28, 2014

Report

Report Number: 1416980-2014-24442
Event Type: Malfunction
Date Received: July 28, 2014
Date of Event: July 3, 2014
Report Date: July 3, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS RETURNED AND AN EVALUATION WAS COMPLETED. A VISUAL INSPECTION OF THE DEVICE WAS PERFORMED AND A CUT WAS IDENTIFIED IN THE TUBING OF THE TRANSFER SET. A LEAK TEST WAS PERFORMED AND VERIFIED THAT THE LEAK WAS ORIGINATING FROM THE CUT IN THE TUBING. A CLAMP FUNCTION TEST AND CLEAR PASSAGE TEST WERE PERFORMED WITH NO ISSUES NOTED. UPON CONCLUSION OF THE INVESTIGATION, THE REPORTED LEAK WAS IDENTIFIED AND FOUND TO ORIGINATE FROM A CUT IN THE TUBING OF THE DEVICE. THE CAUSE OF THE CUT COULD NOT BE DETERMINED. A CAPA HAS BEEN OPENED TO FURTHER INVESTIGATE/ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4).THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A UV FLASH TRANSFER SET LEAKED. THE REPORTER STATED THAT THE LEAK WAS COMING FROM THE SILICONE TUBING, BUT THE EXACT LOCATION OF THE LEAK WAS UNKNOWN. THE LEAK WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
439480	UV FLASH TRANSFER SETS	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1