FDA Adverse Event Malfunction Summary report: N

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

MDR report key: 3240455 · Received July 22, 2013

Report

Report Number: 1416980-2013-19278
Event Type: Malfunction
Date Received: July 22, 2013
Date of Event: June 27, 2013
Report Date: June 27, 2013
Manufacturer: BAXTER HEALTHCARE
Product Code: FKX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT IS FOR SYSTEM ERROR 2240, WHERE THE HOME PATIENT (HP) HAD DISCONNECTED FROM THE HOMECHOICE WITHOUT USING PROPER ASEPTIC TECHNIQUES AND THEN RECONNECTED. 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. IT PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY DISCONNECTING DURING EMERGENCIES. ALSO, IT PROVIDES STEP-BY-STEP INSTRUCTIONS FOR RETURNING TO THERAPY AFTER THE EMERGENCY DISCONNECT PROCEDURE. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ANY RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN TUBING) ON THE HOMECHOICE (HC) DURING DWELL, WHILE THE HP WAS CONNECTED. THE HP HAD DISCONNECTED FROM THE HC WITHOUT USING PROPER DISCONNECT PROCEDURES AND THEN RECONNECTED. THE HP CYCLED THE POWER TO CLEAR THE ALARM. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
340120		SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1				HOMECHOICE