FDA Adverse Event Malfunction Summary report: N

CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD

MDR report key: 1841807 · Received September 22, 2010

Report

Report Number: 1423500-2010-03631
Event Type: Malfunction
Date Received: September 22, 2010
Date of Event: August 29, 2010
Report Date: August 29, 2010
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FKX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). IT IS UNKNOWN IF THE SAMPLE IS AVAILABLE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK HEATER LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DAY FILL. THE HOME PATIENT (HP) STATED THAT THE HEATER BAG WAS FULL. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH TROUBLESHOOTING THE ALARM, BUT THE HC MACHINE KEPT ALARMING, SO THE TSR ASSISTED THE HP TO END THERAPY EARLY AND ADVISED TO CONTACT NURSE. THE HP STATED HE WOULD DO A MANUAL EXCHANGE IN THE MEANTIME. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

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