HOMECHOICE AUTOMATED PD SET WITH CASSETTE

Report

Report Number: 1416980-2013-03803
Event Type: Injury
Date Received: February 14, 2013
Date of Event: January 5, 2013
Report Date: January 25, 2013
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER H12I13067 AND H12G26014. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION.

Description of Event or Problem · 1

THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) WITH DIANEAL THERAPIES. DIANEAL THERAPIES WERE ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY FLUID AND ABDOMINAL PAIN. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT OF PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT FOR THE EVENT INCLUDED AN UNSPECIFIED ANTIBIOTIC. NINE DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT. THE NURSE DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION. SAME PATIENT AS (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
65745	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR		Hospitalization\| R	HOMECHOICE\| DIANEAL PD4 AMBUFLEX