FDA Adverse Event Injury Summary report: N

MINI-CAP, DISCONNECT W/PVP-1SOLUTION

MDR report key: 1884513 · Received October 28, 2010

Report

Report Number: 1423500-2010-05009
Event Type: Injury
Date Received: October 28, 2010
Date of Event: July 1, 2010
Report Date: July 19, 2010
Manufacturer: BAXTER HEALTHCARE - CLEVELAND
Product Code: KDI
PMA / PMN Number: K895631
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AS THE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THIS EVENT INVOLVES THREE BAXTER PRODUCTS. THIS IS REPORT TWO OF THREE.

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOTS (GD874834, GD873927) AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THOSE LOTS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THIS INCIDENT IS UNKNOWN.

Description of Event or Problem · 1

THE HOME PATIENT (HP) CONTACTED (B)(4) REGARDING ASSISTANCE WITH ENDING THERAPY WHILE USING THE HOMECHOICE (HC) CYCLER. THE PATIENT STATED THEY HAD AN INFECTION AND NEEDED TO GO TO THE HOSPITAL. THE PATIENT HAD FIBRIN AND CLOUDY FLUID. (B)(4) ASSISTED THE PATIENT IN ENDING THERAPY. DURING FOLLOW UP CONVERSATION WITH THE PATIENT'S NURSE IT WAS REVEALED THAT THE PATIENT HAD PERITONITIS. THE ORGANISM IDENTIFIED WAS (B)(6). THE PATIENT WAS TREATED WITH (B)(6). THE NURSE INDICATED THAT THE PERITONITIS WAS NOT DIALYSIS RELATED. ADDITIONAL INFORMATION IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MINI-CAP, DISCONNECT W/PVP-1SOLUTION	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	BAXTER HEALTHCARE - CLEVELAND

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR		Hospitalization\| R