MINICAP TRANSFER SET

Report

Report Number: 1416980-2014-15543
Event Type: Injury
Date Received: May 15, 2014
Report Date: April 22, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
PMA / PMN Number: K882498
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PT AS (B)(4).

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13H30047, H13J04064, AND H14A07064 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESSES. 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 PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PT WAS TREATED WITH VANCOMYCIN (2 GRAMS LOADING DOSE PLUS 1 GRAM EVERY 3 DAYS FOR 2 WEEKS AND ROUTE NOT REPORTED) FOR PERITONITIS. ON AN UNREPORTED DATE, THE PT WAS RECOVERED FROM THE EVENT. THREE DAYS AFTER ADMISSION TO THE HOSPITAL, THE PT WAS DISCHARGED. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERED FROM THE PERITONITIS EVENT AND PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THIS IS REPORT 2 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
291876	MINICAP TRANSFER SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R	HOMECHOICE\| HOMECHOICE AUTOMATED PD SET WITH CASSETTE\| DIANEAL PD4 AMBUFLEX