HOMECHOICE

Report

Report Number: 1416980-2013-08977
Event Type: Injury
Date Received: April 10, 2013
Date of Event: March 18, 2013
Report Date: March 20, 2013
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K102936
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NE, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE HOME PATIENT (HP) STATED HE EXPERIENCED A HERNIA AND WAS IMMEDIATELY STARTED ON HEMODIALYSIS. THE HP UNDERWENT A HERNIA REPAIR ON (B)(6) 2013 AND IS SLOWLY RESUMING PERITONEAL DIALYSIS THERAPY. PER THE HP, HE HAS NEVER HAD AN OVERFILL OR IIPV. THE HOME PATIENT IS NOT GOING TO RETURN THE DEVICE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. REVIEW OF THE DEVICE HISTORY AND SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF PATIENT SYMPTOM/HERNIA. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A HERNIA. THE HOME PATIENT DISCONTINUED PERITONEAL DIALYSIS THERAPY AND WAS STARTED ON HEMODIALYSIS THERAPY THE SAME DAY AS THE HERNIA DIAGNOSIS. THE NURSE REPORTED THAT THE HOME PATIENT DID NOT HAVE A PAST MEDICAL HISTORY OF A HERNIA. PER THE PATIENT THE HERNIA WAS NOT RELATED TO PERITONEAL DIALYSIS THERAPY STATING "THE HERNIA SNUCK THRU SCAR TISSUE FROM WHERE THE KIDNEY TRANSPLANT WAS PERFORMED." NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
149832	HOMECHOICE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Required Intervention	DIANEAL PD2 AMBUFLEX 2.5%