FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3893435 · Received June 25, 2014

Report

Report Number: 1416980-2014-20224
Event Type: Malfunction
Date Received: June 25, 2014
Date of Event: May 30, 2014
Report Date: May 31, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AN OPEN CLAMP ON AN UNUSED LINE IS A KNOWN CAUSE OF THIS ALARM. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿ WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE WARNS THE USER TO MAKE SURE ALL CLAMPS ON UNUSED FLUID LINES ARE CLOSED SECURELY. THE GUIDE INSTRUCTS THE USER TO CLOSE ALL CLAMPS WHILE PREPARING TO LOAD THE DISPOSABLE SET. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A SYSTEM ERROR 2240 (AIR IN SET/LINE) ALARM OCCURRED DURING DWELL THREE OF FOUR ON THE HOMECHOICE. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. DURING TROUBLESHOOTING, THE HOME PATIENT (HP) STATED THAT THEY HAD UNCLAMPED AND UNCAPPED THE UNUSED FINAL LINE. THE TECHNICAL SERVICE REPRESENTATIVE REVIEWED PROPER PROCEDURES WITH THE HP. 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
371902	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR			HOMECHOICE