FDA Adverse Event Malfunction Summary report: N

AUTOMATED PD SET W/CASSETTE4 PRONG

MDR report key: 1914888 · Received December 6, 2010

Report

Report Number: 1423500-2010-06553
Event Type: Malfunction
Date Received: December 6, 2010
Date of Event: November 11, 2010
Report Date: November 11, 2010
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE LOT NUMBER IS UNKNOWN AT THIS TIME. THE SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

Additional Manufacturer Narrative · 1

(B)(4). THE REPORTED CONDITION WAS NOT CONFIRMED IN THE LAB DUE TO LACK OF PRODUCT SAMPLE. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BAXTER'S (B)(4) TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, THE HOME PATIENT (HP) STATED HE SET UP SUPPLIES AND STARTED THERAPY WHEN HE NOTICED THE SOLUTION BAG BECAME DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE HP WOULD NEED TO END THERAPY AND START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED 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