MINICAP

Report

Report Number: 1416980-2014-19411
Event Type: Injury
Date Received: June 18, 2014
Date of Event: May 22, 2014
Report Date: May 24, 2014
Manufacturer: BAXTER HEALTHCARE - CLEVELAND
Product Code: KDI
PMA / PMN Number: K895631
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). THE DEVICE WAS NOT RETURNED, THEREFORE AN EVALUATION COULD NOT BE PERFORMED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD896704 AND GD896290 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR AN UNRELATED INDICATION AND ON THE SAME DAY WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND DIARRHEA. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS THE ONSET, THE PATIENT BEGAN TREATMENT WITH FLAGYL (DAILY AND DOSE UNKNOWN) INTRAVENOUS (IV) FOR PERITONITIS. TREATMENT WITH FLAGYL WAS ONGOING. THE PATIENT WAS STILL HOSPITALIZED AND RECOVERING FROM THE PERITONITIS. DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
358965	MINICAP	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	BAXTER HEALTHCARE - CLEVELAND

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Hospitalization\| R	HOMECHOICE, CASSETTE, EXTENSION SET, DIANEAL