FDA Adverse Event Malfunction Summary report: N

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

MDR report key: 3830977 · Received May 23, 2014

Report

Report Number: 1416980-2014-16883
Event Type: Malfunction
Date Received: May 23, 2014
Date of Event: May 1, 2014
Report Date: May 1, 2014
Manufacturer: BAXTER HEALTHCARE
Product Code: FKX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD A SYSTEM ERROR 2240 (AIR IN LINE) ON THE HOMECHOICE (HC) DEVICE DURING AN UNSPECIFIED STEP OF PERITONEAL DIALYSIS (PD) THERAPY. IT WAS UNKNOWN IF THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE NURSE STATED THAT THE PATIENT HAD DISCONNECTED FROM THE MACHINE BUT DID NOT KNOW WHETHER THE PROPER DISCONNECTION PROCEDURE WAS USED. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
307820		SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1				HOMECHOICE PRO