FDA Adverse Event Malfunction Summary report: N

HOMECHOICE CYCLER-REFURBISHED

MDR report key: 1062659 · Received June 11, 2008

Report

Report Number
1423500-2008-00475
Event Type
Malfunction
Date Received
June 11, 2008
Date of Event
May 22, 2008
Report Date
May 22, 2008
Manufacturer
BAXTER HEALTHCARE
Product Code
FKX
PMA / PMN Number
K012988
Product Problem
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT RECEIVING A LOW ULTRAFILTRATION (UF) ALARM WITH THE HOMECHOICE (HC) MACHINE IN DRAIN 4 OF 4. PER THE INITIAL REPORT, THE DRAIN VOLUME WAS 4150 ML. THE TECHNICAL SERVICE REP (TSR) REVIEWED THE PROGRAM SETTINGS WITH THE HOME PT. THE PROGRAMMED FILL VOLUME FOR THIS PT IS 3000 ML. THE PT ALSO HAS A LAST MANUAL DRAIN SETTING WITH A TARGET UF OF 500 ML. THE UF AT THIS POINT WAS ONLY 473 ML. THE HP HAS BEEN SICK AND VOMITING FOR THE PAST WEEK SINCE HAVING KNEE SURGERY. THE HP EVER USED THE WORD OVERFILL OR HAD ANY SYMPTOMS RELATED TO OVERFILL (OTHER THAN VOMITING). THE HP STATED THAT HE NORMALLY DRAINS OVER 4000 ML IN THE LAST DRAIN CYCLE. THE TSR ADVISED THE HP AND HIS CAREGIVER TO LET THE NURSE KNOW OF THIS PROBLEM. THE TSR ASSISTED WITH A BYPASS TO THE LAST FILL CYCLE AS REQUESTED. THE DRAIN VOLUME WAS THEN AT 4123 ML. DURING FOLLOW UP WITH THE HP, HE STATED HE IS FEELING GREAT AND RECOVERED FROM THE SYMPTOMS REPORTED DUE TO KNEE SURGERY. HE DID NOT HAVE ANY SYMPTOMS RELATED TO BEING OVERFILLED. HE REPORTED HE DOES SOMETIMES HAVE LARGE DRAIN VOLUMES, AND HE BELIEVES THIS IS A GOOD THING, BECAUSE HE IS DRAINING OUT MORE TOXINS. HE DOES NOT FEEL THE MACHINE HAS MALFUNCTIONED AND HE HAS NOT HAD ANY PROBLEMS WITH IT. THE HP'S NURSE STATED THAT THE HOME PT MADE HER AWARE OF THIS ISSUE. SHE STATED THAT NO CHANGES WERE MADE TO HIS SETTINGS AND THERAPY IS GOING FINE. THE NURSE AND PT CONFIRMED THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

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 71 YR