FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3813009 · Received May 15, 2014

Report

Report Number: 1416980-2014-15606
Event Type: Malfunction
Date Received: May 15, 2014
Date of Event: April 22, 2014
Report Date: April 22, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, 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 ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL 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) WHILE CYCLING THE POWER IN RESPONSE TO AN ALARM THAT OCCURRED DURING DWELL. THE TECHNICAL SERVICES REPRESENTATIVE ASSISTED THE PATIENT IN CLEARING THE ALARM. DURING TROUBLESHOOTING, NO ABNORMALITIES WERE NOTED THAT COULD HAVE CAUSED OR CONTRIBUTED TO ALARM. THE PATIENT PLANNED TO COMPLETE THERAPY USING MANUAL SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
291192	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR			HOMECHOICE