FDA Adverse Event Injury Summary report: N

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

MDR report key: 4251832 · Received November 14, 2014

Report

Report Number: 1416980-2014-40682
Event Type: Injury
Date Received: November 14, 2014
Date of Event: October 21, 2014
Report Date: October 21, 2014
Manufacturer: BAXTER HEALTHCARE - SWINFORD
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

COMPLAINT NO: CMPLNT-(B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. THIS REPORT INVOLVES THE SAME PATIENT AS IN CMPLNT-(B)(4) AND CMPLNT-(B)(4). THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. 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 PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON THE SAME DAY AS THE ONSET, THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN INJECTION INTRAPERITONEALLY 1 GRAM ONCE A DAY (DURATION NOT REPORTED) AND MEROPENEM INJECTION INTRAVENOUSLY ONCE A DAY (DOSAGE AND DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. IT WAS NOT REPORTED IF DIANEAL THERAPIES WERE ONGOING. IT WAS NOT REPORTED IF THE PATIENT WAS RECOVERING OR WAS RECOVERED FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 3 OF 3.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
738409		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - SWINFORD

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR		Hospitalization\| R	TRANSFER SET, MINICAP\| DIANEAL 1.5% AND 2.5% ULTRABAG