FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3201269 · Received July 2, 2013

Report

Report Number: 1416980-2013-17007
Event Type: Malfunction
Date Received: July 2, 2013
Date of Event: June 7, 2013
Report Date: June 7, 2013
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

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, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM OCCURRED ON THE HOMECHOICE (HC) MACHINE. THIS OCCURRED DURING DRAIN 2 OF 5. THE HOME PATIENT (HP) STATED THAT THE PATIENT LINE DISCONNECTED FROM THE SET-UP AND THE HP NEVER RECONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED WITH THE TROUBLESHOOTING TO CLEAR THE ALARM AND ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES OR FINISH WITH THE MANUAL SUPPLIES. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
300687	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1				HOMECHOICE