FDA Adverse Event Malfunction Summary report: N

HOMECHOICE

MDR report key: 3772200 · Received April 25, 2014

Report

Report Number: 1416980-2014-13294
Event Type: Malfunction
Date Received: April 25, 2014
Date of Event: March 31, 2014
Report Date: March 31, 2014
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: ND, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A SERVICE HISTORY REVIEW SHOWED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY. IN ADDITION, THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). AS THE HOMECHOICE (HC) WAS NOT RETURNED, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A DEVICE HISTORY RECORD REVIEW/SERVICE HISTORY REVIEW WILL BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A HOME PATIENT (HP) EXPERIENCED A HIGH DRAIN 104 ALARM ON A HOMECHOICE (HC) DEVICE DURING PERITONEAL DIALYSIS (PD) THERAPY. THIS ALARM IDENTIFIES THAT THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME, INDICATING AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. THE ALARM OCCURRED AFTER PD THERAPY. THE HP STATED THAT THEY DIDN'T HAVE ANY ISSUES WITH THE PREVIOUS THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
252247	HOMECHOICE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - SINGAPORE

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR