AUTOMATED PD SET W/CASSETTE4 PRONG

MDR report key: 1960389 · Received January 13, 2011

Report

Report Number: 1423500-2011-00561
Event Type: Malfunction
Date Received: January 13, 2011
Date of Event: December 22, 2010
Report Date: December 22, 2010
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

Additional Manufacturer Narrative · 1

(B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR (SE) 2240 (AIR IN LINE) OCCURRED DURING DRAIN 3 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

Description of Event or Problem · 1

A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THERAPY, IN DRAIN CYCLE 3. GTS HAD THE PATIENT CYCLE POWER AND EXPLAINED THE ERROR INDICATED A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET. GTS THEN ADVISED THE PATIENT TO START OVER WITH NEW SUPPLIES. THE PATIENT ELECTED TO CALL HER DIALYSIS NURSE IN THE MORNING TO SEE IF SHE SHOULD DO A MANUAL TRANSFER TOMORROW AND END THERAPY FOR THE NIGHT. NO 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 - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1				HOMECHOICE APD CYCLER