FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 2904303 · Received January 9, 2013

Report

Report Number: 1416980-2013-00649
Event Type: Malfunction
Date Received: January 9, 2013
Date of Event: December 18, 2012
Report Date: December 20, 2012
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A SAMPLE EVALUATION WILL NOT BE CONDUCTED. THE PROBLEM OF USE ERROR, RE-USE OF SINGLE USE PRODUCT WAS CONFIRMED, BASED ON THE PATIENT'S REPORT. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED AS IT IS UNCERTAIN WHY THE PATIENT RE-USED SINGLE USE PRODUCT. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A LABELING REVIEW HAS BEEN PERFORMED, FINDING THAT CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO THE PREVENTION OF THE USE ERROR IN THIS REPORT.

Description of Event or Problem · 1

PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) ON (B)(6) 2012 AND THE HP MENTIONED THAT HE HAD A LOT OF TROUBLE WITH CHECK LINES AND BAGS ALARMS AND HAD CHANGED OUT ONLY THE CASSETTE BEFORE STARTING THE HOMECHOICE BACK UP AGAIN. PRODUCT SURVEILLANCE ADVISED THE HP AGAINST RE-USING SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
10682	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME		H12E14089

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR			HOMECHOICE