FDA Adverse Event Malfunction Summary report: N

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

MDR report key: 2172543 · Received July 22, 2011

Report

Report Number: 1423500-2011-09311
Event Type: Malfunction
Date Received: July 22, 2011
Date of Event: June 24, 2011
Report Date: June 24, 2011
Manufacturer: BAXTER HEALTHCARE
Product Code: FKX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).THE SAMPLE WAS NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE

Description of Event or Problem · 1

A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING 2240 IN DWELL 3 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND POSSIBLE CAUSES TO THE HOME PATIENT (HP), ASSISTED WITH TROUBLESHOOTING, ASSISTED WITH CLEARING THE ALARM AND ADVISED TO CONTACT THE NURSE ABOUT ALARM. THE HP STATED THAT HE WOULD COMPLETE THERAPY WITH MANUAL SUPPLIES. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE HP. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1		SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1				HOMECHOICE