FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 2830645 · Received November 13, 2012

Report

Report Number: 1416980-2012-05015
Event Type: Malfunction
Date Received: November 13, 2012
Date of Event: November 1, 2012
Report Date: November 2, 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; PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE BAG DISCONNECTED. THE HOME PATIENT (HP) STATED THE HEATER BAG BECAME DISCONNECTED. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT CONDUCTED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240 (AIR IN SET) DURING FILL 2 OF 3 ON THE HOME CHOICE (HC). THE HOME PATIENT (HP) STATED THE HEATER BAG BECAME DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INFORMED THE HP THAT AIR HAD BEEN SUCKED INTO THE SYSTEM AND SHE WOULD NEED TO END THERAPY AND START OVER. THE TSR ASSISTED THE HP TO END THERAPY AND ADVISED THE HP TO DISPOSE OF THE CURRENT SUPPLIES USED AND START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

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	80 YR			HOMECHOICE