MINICAP

Report

Report Number: 1416980-2014-20866
Event Type: Injury
Date Received: June 30, 2014
Date of Event: June 3, 2014
Report Date: June 5, 2014
Manufacturer: BAXTER HEALTHCARE - CLEVELAND
Product Code: KDI
PMA / PMN Number: K895631
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD896597 AND GD896589 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 PERITONITIS MANIFESTED BY ABDOMINAL PAIN COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY, AND WAS HOSPITALIZED THE SAME DAY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON THE DAY OF ONSET, THE PATIENT WAS TREATED WITH VANCOMYCIN INTRAPERITONEALLY (DOSAGE AND FREQUENCY NOT REPORTED) FOR THE PERITONITIS. TREATMENT WITH VANCOMYCIN WAS REPORTED TO BE COMPLETE AFTER 23 DAYS OF PRESCRIBED TREATMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER TWO DAYS. IT WAS REPORTED THAT THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. DIANEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 2 OF 4.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
379827	MINICAP	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	BAXTER HEALTHCARE - CLEVELAND

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR		Hospitalization\| R	EXTENSION SET, MINICAP TRANSFER SET, CASSETTE\| HOMECHOICE\| DIANEAL 2.5% AND 4.25% PD4 AMBUFLEX\| DIANEAL 2.5% AND 4.25% ULTRABAG