FDA Adverse Event Malfunction Summary report: N

AUTOMATED PD SET W/CASSETTE4 PRONG

MDR report key: 1823123 · Received September 1, 2010

Report

Report Number: 1423500-2010-03086
Event Type: Malfunction
Date Received: September 1, 2010
Date of Event: August 10, 2010
Report Date: August 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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240 (AIR IN SET). THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE ALARM WAS NOT DETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT INFORMATION WAS UNKNOWN. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

Description of Event or Problem · 1

A CANADA HOME PATIENT (HP) CONTACTED BAXTER'S (B)(4) REGARDING A SYSTEM ERROR 2240 ALARM ON THE HOMECHOICE (HC) DURING DWELL 4 OF 5. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH CLEARING THE ALARM. THE TSR EXPLAINED THE SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP. THE TSR INSTRUCTED THE HP TO COMPLETE THE THERAPY WITH A MANUAL BAG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

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