FDA Adverse Event Injury Summary report: N

MINICAP

MDR report key: 3803125 · Received May 9, 2014

Report

Report Number: 1416980-2014-15047
Event Type: Injury
Date Received: May 9, 2014
Report Date: April 16, 2014
Manufacturer: BAXTER HEALTHCARE - CLEVELAND
Product Code: KDI
PMA / PMN Number: K895631
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. THIS REPORT REFERENCES THE SAME PATIENT AS (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT. ON AN UNREPORTED DATE THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) CEFTAZIDIME (DOSE AND FREQUENCY NOT REPORTED) AND (IP) VANCOMYCIN EVERY 5 DAYS FOR 21 DAYS (DOSE NOT REPORTED). THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS REPORTED THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERED FROM THE 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
281640	MINICAP	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	BAXTER HEALTHCARE - CLEVELAND

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	HOMECHOICE AUTOMATED PD SET WITH CASSETTE\| HOMECHOICE, TRANSFER SET\| DIANEAL PD4 LOW CALCIUM SOLUTION