FDA Adverse Event Injury Summary report: N

MINICAP

MDR report key: 3900654 · Received June 27, 2014

Report

Report Number: 1416980-2014-20744
Event Type: Injury
Date Received: June 27, 2014
Date of Event: April 4, 2014
Report Date: June 4, 2014
Manufacturer: BAXTER HEALTHCARE - CLEVELAND
Product Code: KDI
PMA / PMN Number: K895631
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS IS THE SAME PATIENT AS IN (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD896399 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. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY AND WAS HOSPITALIZED ON THE SAME DAY FOR THE EVENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH VANCOMYCIN FOR ONE WEEK (DOSAGE, ROUTE, FREQUENCY, AND DATES OF TREATMENT NOT REPORTED) FOR THE PERITONITIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER THREE DAYS. IT WAS REPORTED THAT THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. DIANEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 2 OF 2.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
378222	MINICAP	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	BAXTER HEALTHCARE - CLEVELAND

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Hospitalization\| R	HOMECHOICE, CASSETTE\| DIANEAL 2.5%, 4.25% LOW CALCIUM PD4 AMBUFLEX