HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3844473 · Received June 3, 2014

Report

Report Number: 1416980-2014-17745
Event Type: Injury
Date Received: June 3, 2014
Date of Event: April 22, 2014
Report Date: May 8, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS NOT RECEIVED FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED A BLISTER AFTER STEPPING ON AN UNATTACHED CASSETTE CLAMP FROM PD TUBING. IT WAS REPORTED THAT THE BLISTER DEVELOPED INTO A WOUND INFECTION, AND THE PATIENT WAS HOSPITALIZED FOR FOUR WEEKS FOR THIS EVENT. THERAPY WAS REPORTED TO BE ONGOING. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (DOSE, ROUTE AND FREQUENCY NOT SPECIFIED) FOR THIS EVENT. AT THE TIME OF DISCHARGE FROM THE HOSPITAL, THE PATIENT WAS REPORTED TO BE RECOVERING FROM THIS EVENT. AT THE TIME OF THIS REPORT, PHYSICAL THERAPY AND TREATMENT WITH UNSPECIFIED ANTIBIOTICS WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
323647	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Hospitalization\| R	HOMECHOICE\| DIANEAL 2.5% AMBUFLEX