FDA Adverse Event Malfunction Summary report: N

AUTOMATED PD SET W/CASSETTE4 PRONG

MDR report key: 1792015 · Received August 10, 2010

Report

Report Number: 1423500-2010-02352
Event Type: Malfunction
Date Received: August 10, 2010
Date of Event: July 19, 2010
Report Date: July 19, 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). A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. A LABELING REVIEW WAS PERFORMED AND FOUND TO BE ADEQUATE FOR THE USE ERROR IDENTIFIED IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). THE CAUSE OF THE SYSTEM ERROR 2240 WAS DETERMINED TO BE USE ERROR.

Additional Manufacturer Narrative · 1

(B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE), WHICH OCCURRED ON THE HOMECHOICE DURING INITIAL DRAIN. THE HOME PATIENT (HP) STATED HE CONNECTED HIMSELF AFTER HE PRESSED "GO" TO START THE INITIAL DRAIN. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THE PROPER CONNECT AND DISCONNECT PROCEDURE TO THE HP AND ASSISTED THE HP TO CYCLE THE POWER OFF/ON. THE HP WAS ADVISED TO START OVER WITH NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE INITIAL REPORT.

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	62 YR