FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3885241 · Received June 19, 2014

Report

Report Number: 1416980-2014-19532
Event Type: Malfunction
Date Received: June 19, 2014
Date of Event: May 25, 2014
Report Date: May 25, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: ID, 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 SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) OCCURRED ON THE HOMECHOICE (HC) DEVICE DURING DWELL 3 OF 5. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. THE HP STATED THAT THE SUPPLY BAGS WERE EMPTY AND THERE WAS SOLUTION IN THE HEATER BAG ONLY. THE HP INFORMED THE TECHNICAL SERVICE REPRESENTATIVE (TSR) THAT THERE WERE NO BAGS WHICH CAME UNDONE. THERE WAS NOTHING UNUSUAL FOUND DURING THE TROUBLESHOOTING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ALARM. THE TSR EXPLAINED THE ALARM AND INSTRUCTED THE HP TO CYCLE THE POWER ON THE HC TO CLEAR IT. THE HP WOULD COMPLETE THE THERAPY WITH A MANUAL BAG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
361520	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR			HOMECHOICE