FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3894209 · Received June 25, 2014

Report

Report Number: 1416980-2014-20253
Event Type: Malfunction
Date Received: June 25, 2014
Date of Event: May 31, 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: IA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AS THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, A CLAMP BEING LEFT OPEN ON UNUSED SUPPLY LINES IS A KNOWN CAUSE OF THIS ALARM. PER ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿, USERS ARE INSTRUCTED THAT CLAMPS ON ANY UNUSED SOLUTION LINES MUST REMAIN CLOSED WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A SYSTEM ERROR 2240 (AIR IN SET) ALARM OCCURRED ON THE HOMECHOICE DURING DWELL THREE OF FOUR OF PERITONEAL DIALYSIS. DURING TROUBLESHOOTING, IT WAS NOTED THAT THERE WAS AN OPEN CLAMP ON AN UNUSED SUPPLY LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE PATIENT IN CLEARING THE ALARM AND THE PATIENT PLANNED TO START THERAPY OVER USING NEW SUPPLIES. 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
370277	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1				HOMECHOICE