AUTOMATED PD SET W/CASSETTE4 PRONG

Report

Report Number: 1423500-2010-04430
Event Type: Injury
Date Received: October 15, 2010
Date of Event: September 1, 2010
Report Date: September 21, 2010
Manufacturer: BAXTER HEALTHCARE MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER H10F14014 WITH NO DEVIATIONS FROM STANDARD PROCEDURE. THE ROOT CAUSE OF THE REPORTED PROBLEM OF PERITONITIS WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT INFORMATION. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THIS IS THE FIRST OF THREE REPORTS ASSOCIATED WITH THIS EVENT.

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS DISCARDED, THEREFORE, NO EVALUATION WAS PERFORMED.

Description of Event or Problem · 1

ON (B)(6) 2010 HOMECHOICE PERITONEAL DIALYSIS (PD) PATIENT CALLED FOR A CHECK LINE ALARM WHICH WAS RESOLVED OVER THE PHONE. THE PATIENT STATED HE WAS IN THE HOSPITAL OVER THE WEEKEND FOR PERITONITIS. NO ADDITIONAL INFORMATION AVAILABLE.

Description of Event or Problem · 1

ON (B)(6) 2010 WRITER CONTACTED PD NURSE WHO STATED THAT THE PATIENT WENT TO THE ER WITH BELLY PAIN ON (B)(6) 2010 AND WAS DIAGNOSED THAT DAY WITH PERITONITIS. ON (B)(6) 2010 THE PATIENT WAS STARTED ON AN UNKNOWN ANTIBIOTIC. THE PATIENT HAS SINCE RECOVERED AND CONTINUES ON PD THERAPY WITHOUT ANY PROBLEMS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AUTOMATED PD SET W/CASSETTE4 PRONG	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Hospitalization\| R	(B)(4) 1.5 DIANEAL 2L/2L, (B)(4) 1.5 DIANEAL 6L/6L