FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3854440 · Received June 6, 2014

Report

Report Number: 1416980-2014-18272
Event Type: Malfunction
Date Received: June 6, 2014
Date of Event: May 14, 2014
Report Date: May 14, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS REPORTED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, 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 2240 (AIR IN TUBING) ALARM OCCURRED DURING DWELL THREE OF FOUR ON THE HOMECHOICE. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THERE WAS NOTHING FOUND DURING TROUBLESHOOTING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ALARM. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE PATIENT IN CLEARING THE ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
332750	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR			HOMECHOICE