HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3980757 · Received August 5, 2014

Report

Report Number: 1416980-2014-25350
Event Type: Malfunction
Date Received: August 5, 2014
Date of Event: July 11, 2014
Report Date: July 11, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A SYSTEM ERROR 2240 (AIR IN SET) ALARM OCCURRED ON A HOME CHOICE (HC) DEVICE DURING PATIENT USE. THE CAREGIVER (CG) DID NOT KNOW IF THE PATIENT WAS CONNECTED TO THE HOMECHOICE AT THE TIME OF THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ASSISTED IN CLEARING THE ALARM. THE TSR ADVISED THE CG TO START THERAPY OVER WITH NEW SUPPLIES. THERE WAS NOTHING UNUSUAL FOUND DURING THE TROUBLESHOOTING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
458232	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1				HOMECHOICE