FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 2822466 · Received November 7, 2012

Report

Report Number: 1416980-2012-04265
Event Type: Malfunction
Date Received: November 7, 2012
Date of Event: October 13, 2012
Report Date: October 14, 2012
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS CONFIRMED BECAUSE THE PATIENT REPORTED HAVING A CLAMP OPEN ON AN UNUSED SUPPLY LINE DURING THERAPY, A USE ERROR THAT CAN CAUSE SYSTEM ERROR 2240 ALARMS. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR USE/USER ERROR RELATED TO THIS INCIDENT. THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

Description of Event or Problem · 1

THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT AN ISSUE OF SYSTEM ERROR (SE) 2240(AIR IN SET) WHILE ON HOME CHOICE (HC) DEVICE DURING USE, DURING INITIAL DRAIN. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO CYCLE POWER TO THE HC. THE HC ALARMED "WITHES 2367." THE HP STATED THAT HE HAD LEFT THE BLUE CLAMP OWN ON AN UNUSED SUPPLY LINE. THE TSR INFORMED THE HP THAT HE WOULD HAVE TO DISPOSE OF ALL THE CURRENT SUPPLIES AND START OVER. THE HP WILL SETUP THERAPY USING ALL NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR			HOMECHOICE