FDA Adverse Event Malfunction Summary report: N

HOMECHOICE CYCLER-REFURBISHED

MDR report key: 1160604 · Received September 5, 2008

Report

Report Number
1423500-2008-00785
Event Type
Malfunction
Date Received
September 5, 2008
Date of Event
August 18, 2008
Report Date
August 18, 2008
Manufacturer
BAXTER HEALTHCARE
Product Code
FKX
PMA / PMN Number
K923065
Product Problem
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE HOME PATIENT (HP) CONTACTED A TECHNICAL SERVICE REPRESENTATIVE (TSR) AND REPORTED A DRAIN VOLUME OF 4889MLS DURING THE INITIAL DRAIN USING THE HOMECHOICE CYCLER FOR AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THE HP HAD CONTACTED A TSR FOR ASSISTANCE REVIEWING THE CYCLER'S THERAPY LOG DATA. WHILE REVIEWING THE THERAPY LOG CYCLE-BY-CYCLE ULTRAFILTRATION (UF) INFORMATION, THE HP NOTED THAT THE INITIAL DRAIN VOLUME WAS 4889MLS. THE INITIAL DRAIN VOLUME OF 4889MLS WAS 2389MLS GREATER THAN THE HP'S LAST FILL VOLUME OF 2500MLS. ACCORDING TO THE HP, HE HAS NOT FELT BLOATED OR DISTENDED DURING ANY THERAPY AT ALL. THE HP RELATED THAT HE PERFORMS 2 MANUAL PERITONEAL DIALYSIS EXCHANGES DURING THE DAY, PRIOR TO THE START OF THE APD THERAPY USING THE CYCLER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. FOLLOW UP WITH BOTH THE HP AND THE DIALYSIS CENTER NURSE (RN) REVEALED THE HP CONTINUES TO PERFORM APD THERAPY WITHOUT DIFFICULTY. A SWAP OF THE CYCLER WAS SUGGESTED; HOWEVER, BOTH THE HP AND RN REFUSED. SHOULD THE HP EXPERIENCE ANY DIFFICULTY IN THE FUTURE HE WILL CONTACT A TSR FOR ASSISTANCE AT THAT TIME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HOMECHOICE CYCLER-REFURBISHED 78FKX FKX BAXTER HEALTHCARE

Patients

Seq Age Sex Outcome Treatment
1 82 YR