FDA Adverse Event Injury Summary report: N

MINICAP

MDR report key: 3801638 · Received May 9, 2014

Report

Report Number: 1416980-2014-14856
Event Type: Injury
Date Received: May 9, 2014
Report Date: April 14, 2014
Manufacturer: BAXTER HEALTHCARE - CLEVELAND
Product Code: KDI
PMA / PMN Number: K895631
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD896118 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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON AN UNREPORTED DATE THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (DOSE, ROUTE AND FREQUENCY NOT REPORTED). THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT THE PATIENT HAD RECOVERED FROM THIS PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
280112	MINICAP	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	BAXTER HEALTHCARE - CLEVELAND

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R	HOMECHOICE AUTOMATED PD SET WITH CASSETTE\| HOMECHOICE, MINICAP TRANSFER SET\| DIANEAL PD4 2.5% AND 4.25% SOLUTIONS