FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3800189 · Received May 8, 2014

Report

Report Number: 1416980-2014-14825
Event Type: Malfunction
Date Received: May 8, 2014
Date of Event: April 13, 2014
Report Date: April 13, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. PER ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿, USERS ARE NOT INSTRUCTED TO DISCONNECT DURING THERAPY UNLESS FOR AN EMERGENCY DISCONNECT PROCEDURE. THE PATIENT GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR RETURNING TO THERAPY AFTER THE EMERGENCY DISCONNECT PROCEDURE. 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

THIS IS A REPORT OF A HOME PATIENT WHO HAD A SYSTEM ERROR 2240 (AIR IN TUBING) ALARM ON THE HOMECHOICE (HC) WHILE CONNECTED DURING DWELL. DURING TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT HAD DISCONNECTED DURING THE DWELL PHASE WITH THIRTY-TWO MINUTES LEFT AND WAS CURRENTLY RECONNECTED TO THE PATIENT LINE. THE POWER WAS CYCLED TO CLEAR THE ALARM AND THE PATIENT WAS ADVISED 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
279276	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