FDA Adverse Event Injury Summary report: N

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

MDR report key: 4181989 · Received October 17, 2014

Report

Report Number: 1416980-2014-36300
Event Type: Injury
Date Received: October 17, 2014
Date of Event: September 12, 2014
Report Date: September 22, 2014
Manufacturer: BAXTER HEALTHCARE - SWINFORD
Product Code: KDJ
PMA / PMN Number: K894783
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS IS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THIS EVENT ONE DAY AFTER ONSET. TREATMENT FOR THIS EVENT WAS VANCOMYCIN (INTRAPERITONEALLY, DOSE, FREQUENCY AND DURATION NOT REPORTED) AS WELL AS TWO UNKNOWN ANTIBIOTICS (ORALLY, DOES, FREQUENCY AND DURATION NOT REPORTED). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL SIX DAYS AFTER ADMISSION. PERITONEAL DIALYSIS THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT IS RECOVERING FROM THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 4.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
660154		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - SWINFORD

Patients

Seq	Age	Sex	Outcome	Treatment
1	82 YR		Hospitalization\| R	CASSETTE, HOMECHOICE, 2.5% DIANEAL PD4\| TRANSFER SET, MINICAP, 1.5% DIANEAL PD4,