FDA Adverse Event Malfunction Summary report: N

EXTENSION SET

MDR report key: 3935176 · Received July 15, 2014

Report

Report Number: 1416980-2014-22625
Event Type: Malfunction
Date Received: July 15, 2014
Date of Event: June 20, 2014
Report Date: June 20, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
PMA / PMN Number: K925403
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND A LOT NUMBER WAS NOT PROVIDED; THEREFORE, NO EVALUATION COULD BE PERFORMED. HOWEVER, ANIMAL DAMAGE WAS REPORTED AND IS KNOWN TO BE ABLE TO CAUSE THE REPORTED ISSUE. PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿ WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE WARNS THE USER THAT CONTAMINATION OF THE FLUID OR FLUID PATHWAYS CAN RESULT IF A PET OR ANIMAL BITES A SOLUTION BAG OR THE DISPOSABLE SET. THE GUIDE INSTRUCTS, IN ORDER TO REDUCE THIS RISK, THE PATIENT SHOULD NOT PERFORM DIALYSIS IN THE SAME ROOM AS PETS OR ANIMALS. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT'S CAT PUNCTURED THE PATIENT LINE EXTENSION DURING DWELL 4 OF 4. THE PATIENT WAS CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE PATIENT IN ENDING THERAPY. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
412042	EXTENSION SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR			HOMECHOICE