MINICAP TRANSFER SET

Report

Report Number: 1416980-2014-24541
Event Type: Injury
Date Received: July 29, 2014
Date of Event: July 3, 2014
Report Date: July 4, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
PMA / PMN Number: K882498
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

COMPLAINT NO: (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13K14046 AND H13K26065 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. AS THE SAMPLE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY AS ONSET OF THE PERITONITIS. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS INTRAPERITONEALLY, POSSIBLY ¿CEFEPIME AND VANCO¿ (DOSE AND FREQUENCY NOT REPORTED); HOWEVER, THE DRUGS WERE NOT MEDICALLY CONFIRMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN THE SAME MONTH AS ADMISSION AND HAD RECOVERED FROM THE PERITONITIS EVENT. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 5 OF 5 INVOLVED IN THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
441380	MINICAP TRANSFER SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	13 YR		Hospitalization\| R	DIANEAL\| Y- SET\| CASSETTE\| MINICAP\| FLEXICAP\| HOMECHOICE