EXTENSION SET

Report

Report Number: 1416980-2014-17028
Event Type: Injury
Date Received: May 27, 2014
Date of Event: April 21, 2014
Report Date: May 2, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
PMA / PMN Number: K925403
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14A11033 AND H14C15071 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED BACTERIAL PERITONITIS MANIFESTED AS ABDOMINAL PAIN COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON THAT SAME DAY AS THE ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE IN THE SAME MONTH, THE PATIENT BEGAN TREATMENT WITH UNSPECIFIED ANTIBIOTICS FOR PERITONITIS. SIX DAYS AFTER THE ONSET AND HOSPITALIZATION, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RECOVERING FROM THE PERITONITIS AT THE TIME OF THE REPORT. DIANEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 4.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
311411	EXTENSION SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Hospitalization\| R	DIANEAL 2.5% AND 4.25% AMBUFLEX,\| HOMECHOICE AUTOMATED PD SET WITH CASSETTE\| HOMCHOICE, MINICAP TRANSFER SET, MINICAP,