FDA Adverse Event Injury Summary report: N

MINICAP

MDR report key: 3830071 · Received May 23, 2014

Report

Report Number: 1416980-2014-16779
Event Type: Injury
Date Received: May 23, 2014
Date of Event: April 12, 2014
Report Date: April 28, 2014
Manufacturer: BAXTER HEALTHCARE - CLEVELAND
Product Code: KDI
PMA / PMN Number: K895631
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD896126 AND GD896209 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 AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PT AS (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND A FEVER. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. THE PT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PT WAS TREATED WITH VANCOMYCIN IP ONE GRAM EVERY THREE DAYS. FIFTEEN DAYS AFTER THE ONSET OF PERITONITIS, THE PT WAS RECOVERED FROM THE EVENT. ON AN UNREPORTED DATE, THE PT WAS RETRAINED (PROPHYLACTICALLY) IN ASEPTIC TECHNIQUE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THIS IS REPORT 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
308452	MINICAP	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	BAXTER HEALTHCARE - CLEVELAND

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR		Required Intervention	HOMECHOICE\| CASSETTE\| FLEXICAP\| EXTENSION SET\| DIANEAL 1.5% AND 2.5% PD4