FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3855198 · Received June 9, 2014

Report

Report Number: 1416980-2014-18316
Event Type: Malfunction
Date Received: June 9, 2014
Date of Event: May 17, 2014
Report Date: May 17, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE PATIENT REPORTED THAT THEY HAD NOT OPENED THE CLAMP ON THE PATIENT LINE DURING PRIMING. 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 INFORMS THE USER TO OPEN CLAMPS ON LINES CONNECTED TO SOLUTION BAGS AND THE PATIENT LINE TO ENSURE PROPER PRIMING. THE GUIDE INSTRUCTS THE USER TO CHECK THE LINES FOR CLOSED CLAMPS. 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 PATIENT LINE ALARM, THE HOME PATIENT (HP) STATED THAT THEY HAD NOT OPENED THE CLAMP ON THE PATIENT LINE DURING PRIMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE PATIENT IN ENDING THERAPY AND ADVISED THE HP TO RESTART THERAPY USING ALL NEW SUPPLIES. 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
335132	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR			HOMECHOICE