BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2110550 · Received June 1, 2011

    Report

    Report Number
    1423500-2011-06912
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 7, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE CAUSE OF THE SYSTEM ERROR 2240 WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THERE WAS AN OPEN CLAMP ON UNUSED SUPPLY LINE. HOME PATIENT STATED THAT THE FINAL LINE WAS UNCAPPED AND THE CLAMP WAS OPEN BECAUSE SHE WAS SUPPOSED TO HOOK A BAG UP TO IT BUT SHE FORGOT. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO E ADEQUATE FOR A USE/USER ERROR IDENTIFIED IN THIS INCIDENT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE THE PRODUCT CODE IS UNKNOWN, THERE WILL NOT BE A 510K NUMBER PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) REPORTED TO BAXTER THAT A SYSTEM ERROR (SE) 2240 ALARM OCCURRED ON THE HOMECHOICE (HC) MACHINE DURING DWELL 3 OF 4 DURING THERAPY. THE PATIENT WAS CONNECTED TO THE MACHINE. THE HP STATED THERE WAS AN OPEN CLAMP ON UNUSED SUPPLY LINES; THE HP STATED THAT THE FINAL LINE WAS UNCAPPED AND THE CLAMP WAS OPEN BECAUSE SHE WAS SUPPOSED TO HOOK A BAG UP TO IT BUT SHE FORGOT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO CYCLE POWER TO CLEAR THE ALARM. THE HP STATED SHE WOULD DISCONTINUE THERAPY SINCE SHE WAS ALREADY IN DWELL 3 OF 4 AND LET THE NURSE KNOW WHAT HAPPENED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE PRO