FDA Adverse Event Malfunction Summary report: N

AUTOMATED PD SET W/CASSETTE4 PRONG

MDR report key: 1790144 · Received August 10, 2010

Report

Report Number: 1423500-2010-02309
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 LABELING REVIEW WAS PERFORMED AND FOUND TO BE ADEQUATE FOR THE POTENTIAL USE ERROR IDENTIFIED IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

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) ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 3. THE HOME PATIENT (HP) STATED SHE DISCONNECTED AND RECONNECTED TO USE THE RESTROOM DURING DWELL 3. THE HP WAS CONNECTED AT THE TIME OF THE CALL. THE HP WAS ADVISED TO DISCARD THE SUPPLIES AND REPORT THE ALARM TO THE PERITONEAL DIALYSIS NURSE IN THE MORNING. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CALLER. 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	72 YR