FDA Adverse Event Malfunction Summary report: N

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

MDR report key: 4550430 · Received February 26, 2015

Report

Report Number: 1416980-2015-07549
Event Type: Malfunction
Date Received: February 26, 2015
Date of Event: February 1, 2015
Report Date: February 1, 2015
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS IS A REPORT OF AIR IN A LINE WHERE THE SUPPLY LINE WAS NOT PROPERLY PRIMED. ATTEMPTING TO PRIME THE CASSETTE WITHOUT OPENING THE SUPPLY LINE CLAMP IS A KNOWN CAUSE OF THIS EVENT. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO SYSTEMS PATIENT AT-HOME GUIDE¿, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE INFORMS THE USER TO OPEN CLAMPS ON LINES CONNECTED TO SOLUTION BAGS AND THE PATIENT LINE TO ENSURE PROPER PRIMING. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED AIR IN THE SUPPLY LINE OF A HOMECHOICE CASSETTE WITHOUT AN ALARM. THIS OCCURRED DURING FILL THREE OF FIVE OF PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS CONNECTED AT THE TIME OF THE EVENT. DURING TROUBLESHOOTING, IT WAS DISCOVERED THAT THE PATIENT DID NOT OPEN THE SUPPLY LINE CLAMP DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
135581		SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR			HOMECHOICE