FDA Adverse Event Malfunction Summary report: N

AUTOMATED PD SET W/CASSETTE4 PRONG

MDR report key: 1914492 · Received December 3, 2010

Report

Report Number: 1423500-2010-06494
Event Type: Malfunction
Date Received: December 3, 2010
Date of Event: November 10, 2010
Report Date: November 10, 2010
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRING DURING DWELL 3 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

Description of Event or Problem · 1

A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING DWELL 3. POWER WAS CYCLED AND THE HC ALARMED SYSTEM ERROR 2367. GTS ASSISTED THE HOME PATIENT (HP) WITH ENDING THERAPY AND ADVISED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) OR NEW DISPOSABLES. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED THAT SHE DRAINED OUT THAT NIGHT, AND THEN WAS ABLE TO RESUME THERAPY SUCCESSFULLY THE NEXT NIGHT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AUTOMATED PD SET W/CASSETTE4 PRONG	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1