HOMECHOICE AUTOMATED PD SET WITH CASSETTE

Report

Report Number: 1423500-2011-05616
Event Type: Injury
Date Received: May 6, 2011
Date of Event: February 1, 2011
Report Date: April 12, 2011
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS H10K04081, H10K16010 AND H10L14013 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. ROOT CAUSE WAS DETERMINED AS USER ERROR- POOR ASEPTIC TECHNIQUE. CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO THE PREVENTION OF USER ERROR- POOR ASEPTIC TECHNIQUE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

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. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

Description of Event or Problem · 1

DURING A CALL TO BAXTER ON (B)(6) 2011, THE HOMEPATIENT (HP) REPORTED THAT ON AN UNREPORTED DATE IN 2011, JUST PRIOR TO THE ONSET OF SYMPTOMS, THAT HE HAD EXPERIENCED A "CONNECTION ISSUE", AND ON (B)(6) 2011 EXPERIENCED SYMPTOMS OF PERITONITIS. ON AN UNREPORTED DATE IN (B)(6) 2011, A PERITONEAL DIALYSIS (PD) EFFLUENT CULTURE WAS PERFORMED. NO HOSPITALIZATION WAS REQUIRED AND TREATMENT WAS NOT REPORTED, BUT WAS PERFORMED AT HOME. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR		Other	HOMECHOICE\| LOWCAL (PD4) AMBUFLEX