FDA Adverse Event Malfunction Summary report: N

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

MDR report key: 3770870 · Received April 24, 2014

Report

Report Number: 1416980-2014-13209
Event Type: Malfunction
Date Received: April 24, 2014
Date of Event: March 31, 2014
Report Date: March 31, 2014
Manufacturer: BAXTER HEALTHCARE - SWINFORD
Product Code: KDJ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). (B)(6). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE DEVICE WAS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS RETURNED AND ANALYZED. NO ABNORMALITIES WERE IDENTIFIED DURING VISUAL INSPECTION AND ALL DIMENSIONS MEASURED WITHIN SPECIFICATION LIMITATIONS. THE DISCONNECT CAP WAS CONNECTED TO A TEST TRANSFER SET AND AN UNDERWATER PRESSURE TEST WAS PERFORMED. NO ISSUES WERE NOTED DURING FUNCTIONAL TESTING. THE PROBLEM WAS UNABLE TO BE CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A MIS-SPIKE OCCURRED WHEN ATTEMPT TO CONNECT THE TRANSFER SET TO THE CONNECTOR COVER BY CLEAN FLASH. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
248949		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - SWINFORD

Patients

Seq	Age	Sex	Outcome	Treatment
1				TRANSFER SET