MINI-CAP, DISCONNECT W/PVP-1SOLUTION

Report

Report Number: 1423500-2010-02358
Event Type: Injury
Date Received: August 10, 2010
Date of Event: June 7, 2010
Report Date: June 7, 2010
Manufacturer: BAXTER HEALTHCARE - CLEVELAND
Product Code: KDI
PMA / PMN Number: K895631
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AS THE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS CONDUCTED ON ASSOCIATED LOTS (GD872929) 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 EVENT COULD NOT BE DETERMINED UPON COMPLETION OF BAXTER'S INVESTIGATION OF THIS INCIDENT.

Additional Manufacturer Narrative · 1

(B)(4). THE REPORT OF PERITONITIS WAS DIAGNOSED ON (B)(6), 2010. THE CAUSE OF THE PERITONITIS WAS TOUCH CONTAMINATION. A CULTURE WAS PERFORMED BUT RESULTS WERE UNKNOWN. THE PATIENT IS RECOVERING.

Description of Event or Problem · 1

THIS IS A REPORT OF A HOMECHOICE PATIENT (HP) WHO REPORTED HAVING PAIN DURING DRAIN CYCLES. THE NURSE STATED THAT ON (B)(6) 2010, THE PATIENT HAD NO EVIDENCE OF PERITONITIS. ON (B)(6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PERITONITIS AND DISCHARGED ON (B)(6) 2010. THE NURSE DOES NOT KNOW THE CAUSE OF THE PERITONITIS. THIS IS REPORT 2 OF 2 AND IS FOR THE PERITONITIS INVESTIGATION AGAINST THE MINICAP.

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	61 YR		Hospitalization\| R