FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3873160 · Received June 13, 2014

Report

Report Number: 1416980-2014-18981
Event Type: Malfunction
Date Received: June 13, 2014
Date of Event: May 20, 2014
Report Date: May 20, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS IS A REPORT OF A USE ERROR, WHERE THE PATIENT WAS CONNECTED DURING PRIME. 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 PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET AND WARNS THE USER NOT TO CONNECT TO THE PATIENT LINE UNLESS THE FLUID LEVEL IS AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE. THE GUIDE ALSO PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY REPRIMING THE PATIENT LINE. 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

DURING TROUBLESHOOTING FOR A CHECK LINES AND BAGS ALARM ON THE HOMECHOICE (HC) MACHINE, IT WAS DISCOVERED THAT THE HOME PATIENT (HP) WAS CONNECTED TO THE HC DURING PRIMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO DISCONNECT AND START THERAPY OVER WITH NEW SUPPLIES. THERE WAS NO REPORT OF 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
351090	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR			HOMECHOICE