MINICAP

Report

Report Number: 1416980-2014-18100
Event Type: Injury
Date Received: June 5, 2014
Date of Event: May 11, 2014
Report Date: May 15, 2014
Manufacturer: BAXTER HEALTHCARE - CLEVELAND
Product Code: KDI
PMA / PMN Number: K895631
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD896407 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.

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. PD THERAPY WAS REPORTED TO BE ONGOING. IT WAS REPORTED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS EVENT. THE PERITONITIS WAS REPORTED TO HAVE MANIFESTED BY STOMACH PAIN, CLOUDY EFFLUENT AND DIARRHEA. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (DOSE, ROUTE AND FREQUENCY UNKNOWN) FOR THE EVENT. AT THE TIME OF THIS REPORT THE PATIENT HAD NOT RECOVERED FROM THE PERITONITIS AND ANTIBIOTIC THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
328795	MINICAP	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	BAXTER HEALTHCARE - CLEVELAND

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Required Intervention	DIANEAL PD4 ULTRABAG