FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3183691 · Received June 22, 2013

Report

Report Number: 1416980-2013-16232
Event Type: Malfunction
Date Received: June 22, 2013
Date of Event: June 3, 2013
Report Date: June 3, 2013
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
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 AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

THIS IS A REPORT OF A HOME PATIENT (HP) WHO HAD A SYSTEM ERROR 2367(RESUME ERROR, CRITICAL ERROR FOUND) ON THE HOMECHOICE (HC) FOLLOWING A POWER OUTAGE DURING DWELL. AFTER REVIEWING THE LOG, NO ALARMS WERE FOUND THAT PRECEDED THE SYSTEM ERROR 2367. THE PATIENT WAS ABLE TO CLEAR THE ALARM. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
284464	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR			HOMECHOICE