FDA Adverse Event Malfunction Summary report: N

CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD

MDR report key: 1871803 · Received October 16, 2010

Report

Report Number: 1423500-2010-04469
Event Type: Malfunction
Date Received: October 16, 2010
Date of Event: September 21, 2010
Report Date: September 21, 2010
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FKX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE AVAILABILITY IS UNKNOWN AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

Additional Manufacturer Narrative · 1

(B)(4).UPON FURTHER INVESTIGATION BY BAXTER THE DEVICE PROGRAMMING HAD BEEN CHANGED TO REDUCE THE NUMBER OF CYCLES. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A PROGRAM CHANGE ON THE HOMECHOICE (HC) DURING USE. THE HOME PATIENT (HP) REPORTED THE HC WAS SHOWING FILL 1 OF 3 INSTEAD OF 1 OF 6. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE PROGRAMMING MUST HAVE BEEN CHANGED TO REDUCE THE CYCLES. HC WAS CURRENTLY IN DWELL 1 OF 3. TSR HAD HP CHECK THE PROGRAMMING AND EXPLAINED THE HP NEEDED TO CONTACT THE HOSPITAL TO HAVE THE PROGRAMMING CHECKED. HP WILL COMPLETE THERAPY ON THE MACHINE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - SINGAPORE

Patients

Seq	Age	Sex	Outcome	Treatment
1