BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

    MDR report key: 1900836 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05836
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB. NO PROBLEMS WERE REVEALED DURING THIS INSPECTION AND ALL CONNECTIONS WERE CORRECT AND SECURE. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED IN THE DEVICE LOG WAS DETERMINED TO INSUFFICIENT DRAIN - FALSE EMPTY DETECT AND LAST MANUAL DRAIN NOT USED. A DEVICE HISTORY REVIEW REVEALED THE DEVICE WAS REWORKED AND PASSED ALL SUBSEQUENT TESTING. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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 HAS NOT YET BEEN RECEIVED BUT AN EVALUATION IS EXPECTED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE REGISTERED NURSE (RN) CONTACTED BAXTER'S TECHNICAL SERVICE WANTING TO KNOW WHY THE HOME PATIENT (HP) WAS HAVING A NEGATIVE ULTRAFILTRATION (UF). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED HOW THE HP CAN HAVE NEGATIVE UF NUMBERS. THE RN STATED THAT THE HP HAS BEEN HAVING THE NEGATIVE UF NUMBERS AND HAD AN INITIAL DRAIN VOLUME OF 3960ML. THE TSR ASKED THE HP TO DRAIN MANUALLY. THE TSR EXPLAINED THAT THE HP MAY BE A POSITIONAL DRAINER. THE HP STATED THAT HE STARTED TO DRAIN AND THEN THE DRAIN STOPPED. THE TSR ASKED THE HP IF HE HAD THE BANDAGE AROUND THE CATHETER AND THE HP STATED NO. THE TSR HAD THE HP REPOSITION AND THE HP STATED THAT HE WAS DRAINING. THE HP STATED THAT HE WAS NOT DRAINING ANY MORE. THE HP DRAINED OUT ABOUT 3000ML AND STATED THAT HE FELT BETTER. THE TSR RECOMMENDED THAT THE HP USE MANUAL BAGS FOR TONIGHT. THE TSR EXPLAINED THAT THE HC WOULD BE SWAPPED AND EXPLAINED THE UPS SWAP PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THIS EVENT MEETS OVERFILL CRITERIA. ON (B)(6) 2010, PRODUCT SURVEILLANCE CONTACTED THE HP PERITONEAL DIALYSIS NURSE (PDN). THE PDN STATED THE HP RECEIVED THE NEW HC AND HAD A UF OF 400ML AND IDV OF 1760ML. THE PDN STATED THE HC ALARMED AGAIN WITH A LDV DURING THE NIGHT. THE PDN STATED THEY ARE GOING TO DO A CATSCAN TO CHECK THE CATHETER AGAIN AND HAVE THE HP SEE THE SURGEON. THE PDN STATED THIS WAS NOT A CYCLER ISSUE BECAUSE THE HP HAS HAD MULTIPLE HC MACHINES AND CONTINUES TO HAVE PROBLEMS WITH THERAPY. THE PDN STATED THE HP HAS BEEN ON DIALYSIS SINCE HE WAS A SMALL CHILD AND HAS HAD MULTIPLE FAILED TRANSPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1