BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1962002 · Received January 17, 2011

    Report

    Report Number
    1423500-2011-00693
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION BY THE PRODUCT ANALYSIS LAB. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS UNDETERMINED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH ((B)(4)).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, THE HOME PATIENT (HP) STATED HAD BEEN ON THE HC SINCE 9:30PM LAST NIGHT AND WAS ONLY IN CYCLE 2 OF 5, DRAIN VOLUME 3500ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) MONITORED THE HP THROUGH DRAIN 2 OF 5 AND THE DRAIN VOLUME REACHED 4077ML BEFORE THE HP STOPPED DUE TO CRAMPING. THE TSR ENDED THERAPY IN DRAIN 2 OF 5. DURING THIS TIME, THE HP'S WEIGHT WAS (B)(6) AND AT THE START OF THERAPY THE HP'S WEIGHT WAS (B)(6). THE TSR CONTACTED THE PERITONEAL DIALYSIS NURSE (PDN) AND INFORMED OF THE FINDINGS. THE HP AND PDN DID NOT WANT TO SWAP THE HC. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE CAREGIVER (CG) REGARDING A DIFFERENT ISSUE ON (B)(4) 2011 WHEN THE CG STATED THAT THE HP HAD AN OVERFILL ON THEIR HOMECHOICE ON (B)(6) 2011. THE HP USES 3 BAGS FOR THERAPY (1 - 2.5% AT 6L, 1 - 1.5% AT 6L, AND 1 - 2.5% AT 2L). WHEN THE HP WOKE UP IN THE MORNING, THE CYCLER WAS ON FILL 2 OF 5 AT 9AM. THE CG STATED THAT CYCLE 2 OF 5 IS USUALLY AROUND 11PM/ 12AM AT NIGHT. THE CG STATED THAT THE HP HAD DRAINED OVER 4077ML, THEY STOPPED DRAINING DUE TO THE HP FEELING CRAMPS. THE CG STATED THAT THE HP USED MANUALS FOR DAY THERAPY ((B)(6) 2011) AND RETURNED TO THE CYCLER THE FOLLOWING NIGHT. THE HP HAD NOT HAD ANY OTHER ISSUES. THE HP WILL SEE HIS NURSE ON (B)(6) 2011 IN THE AFTERNOON. HE HAD A 24 HOUR URINE TEST WHICH HE WILL BRING IN TO THE CLINIC WHEN HE SEES HIS NURSE. ON (B)(4) 2011 PRODUCT SURVEILLANCE CONTACTED THE HP'S PDN REGARDING THE REPORT OF OVERFILL. THE PDN STATED THE HP WAS AT THE CLINIC YESTERDAY ((B)(6) 2011) FOR ROUTINE LABS AND WAS DOING FINE. THE PDN DID NOT REQUEST SWAP. THE PDN STATED THE HP HAS NOT REPORTED ANY SYMPTOMS OR OTHER DRAIN VOLUMES THAT MEET INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA. THE PDN CONFIRMED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT AND THAT THE HP WAS DOING WELL WITH THE FOLLOWING TREATMENTS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR DIANEAL LOW CAL, SINGLE BAG DEXTROSE 4.25%| DIANEAL LOW CAL, SINGLE BAG DEXTROSE 2.50%| DIANEAL LOW CAL, ULTRA BAG DEXTROSE 1.50%| DIANEAL LOW CAL, SINGLE BAG DEXTROSE 4.25%| DIANEAL LOW CAL, SINGLE BAG DEXTROSE 2.50%| DIANEAL LOW CAL, ULTRA BAG DEXTROSE 2.50%| EXTRANEAL, SINGLE BAG 7.5% ICODEXTRIN| DIANEAL LOW CAL, ULTRA BAG DEXTROSE 4.25%| DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%| DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%