FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3915742 · Received July 7, 2014

Report

Report Number: 1416980-2014-21652
Event Type: Malfunction
Date Received: July 7, 2014
Date of Event: June 12, 2014
Report Date: June 12, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2267 ALARM (AIR IN SET/LINE) OCCURRED ON THE HOMECHOICE (HC) DEVICE DURING USE. THE CAREGIVER (CG) ALREADY CLEARED THE ALARM AND HAD THE HOME PATIENT (HP) DISCONNECT FROM THE SETUP. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO START OVER WITH NEW SUPPLIES OR USE MANUAL BAGS. THE TROUBLESHOOTING WITH THE TSR DID NOT DETERMINE WHAT CAUSED THE ALARM. 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
393361	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR			HOMECHOICE