MINI-CAP, DISCONNECT W/PVP-1SOLUTION

Report

Report Number: 1423500-2010-03105
Event Type: Injury
Date Received: September 2, 2010
Date of Event: August 1, 2010
Report Date: August 11, 2010
Manufacturer: BAXTER HEALTHCARE - CLEVELAND
Product Code: KDI
PMA / PMN Number: K895631
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD874859 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. NO LABELING DEFICIENCIES OR ERRORS WERE ALLEGED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS IS THE FOURTH OF FOUR COMPLAINTS ASSOCIATED WITH THIS EVENT.

Description of Event or Problem · 1

THIS IS A REPORT BY A NURSE REGARDING PERITONITIS IN A (B)(6) FEMALE HOMECHOICE PERITONEAL DIALYSIS (PD) PATIENT. ON (B)(6) 2010 THE PERITONEAL DIALYSIS NURSE REPORTED THAT THE PATIENT HAD BEEN IN THE HOSPITAL FOR APPROXIMATELY ONE MONTH. IT WAS UNKNOWN WHAT REMEDIAL TREATMENT WAS NEEDED. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. NO ADDITIONAL INFORMATION WAS 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	48 YR		Hospitalization\| R	(B)(4) 1.5% LO/CAL UB 2L/2L DNL 5B9770 1.5% LO/CAL